Body fluid lancing, acquiring, and testing cartridge design

ABSTRACT

A disposable device for analyzing body fluid especially for blood sugar tests includes a container which can be inserted into a measuring apparatus, a sampling member provided in the container to pierce skin of a body part and sample body fluid, and a test member for receiving body fluid obtained by the skin-piercing. In one form, the test member is fixed in a retaining chamber of the container, and the sampling member is configured in the same retaining chamber such that it is separated at a distance from the test member in an initial state and is in contact with the test member to transfer body fluid in a transfer state after the skin-piercing.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of U.S. application Ser. No.12/568,009, filed Sep. 28, 2009, which is hereby incorporated byreference. This application is a continuation-in-part of InternationalPatent Application No. PCT/EP2008/062130, filed Sep. 12, 2008, whichclaims the benefit of U.S. Provisional Application No. 60/972,996, filedSep. 17, 2007, which are hereby incorporated by reference.

BACKGROUND

The present invention generally relates to an integrated disposablecartridge and more specifically, but not exclusively, concerns acartridge manufactured in a cost-effective manner. Moreover, theintegrated disposable includes a unique technique of transferring afluid sample from a lancet to a test section.

The present invention also generally concerns a disposable device foranalyzing body fluid especially for blood sugar tests comprising acontainer which can be inserted into a measuring apparatus, a samplingmember provided in the container to pierce skin of a body part andsample body fluid, and a test member for receiving body fluid obtainedby the skin-piercing. The invention further concerns an accordinganalyzing process.

The acquisition and testing of body fluids is useful for many purposesand continues to grow in importance for use in medical diagnosis andtreatment, such as for diabetes, and in other diverse applications. Inthe medical field, it is desirable for lay operators to perform testsroutinely, quickly, and reproducibly outside of a laboratory setting,with rapid results and a readout of the resulting test information.Testing can be performed on various body fluids and, for certainapplications, is particularly related to the testing of blood and/orinterstitial fluid. Performing home-based testing can be difficult formany patients, especially for patients with limited hand dexterity, suchas the elderly or diabetics. For example, diabetics can sometimesexperience numbness or tingling in their extremities, such as theirhands, which can make self-testing difficult because they are unable toaccurately position a test strip to collect the blood sample. Inaddition, wounds for diabetics tend to heal more slowly, and as aresult, there is a desire to make incisions less invasive.

Various methods and withdrawal devices for small amounts of body fluidsare used above all by diabetics for the self-monitoring of blood sugarwhich should be carried out several times daily. Recent conceptsenvisage a microneedle including a test element as a disposable in ahand-held device to generate a skin puncture, to remove a small amountof blood therefrom utilizing capillary forces and to analyse this bloodsample. Generally, in such devices the lancing member and the testelement are monolithically integrated and must be handled as combinedunits, where the lancing and blood transfer require separate actuation.

Recently, lancet integrated test strips or elements have been developedin which a test strip is integrated with a lancet or other piercingmeans so as to form a single disposable unit. While these integratedunits have somewhat simplified the collection and testing of fluidsamples, there are still a number of issues that need to be resolvedbefore a commercial unit can be implemented. A few concerns for amultiple disposable unit include manufacturing the unit simply andinexpensively and positioning individual lancets and test strips in thecommercial unit without damage to either the test strip or the lancet.Typically, a plurality of lancets and a plurality of test strips areeach individually positioned in sealed compartments in a commercialunit. This process can be time consuming, expensive, and difficult tomanufacture. Moreover, there is a possibility some of the lancets and/ortest strips can be damaged while being positioned in the commercialunit.

Another concern of multiple disposable units disposed in a commercialunit is sterility of the lancets both initially and to maintain thesterility of the lancets until lancing the skin or tissue. As should beappreciated, sterilizing the lancets separately from the test sectionseases the manufacturing process of a commercial unit. For example, thechemistry on the test sections is not disturbed by the separatesterilization of the lancets. After the lancets and test sections areassembled together, it is important to maintain the sterility of thelancets until lancing the skin or tissue to ensure an accurate testingevent.

Yet another concern of multiple disposable units disposed in acommercial unit is the alignment of the lancet and test strip. Properlyaligning the lancet and test strip ensures an accurate transfer of abody fluid sample from the lancet to the test strip. Moreover the properalignment of the lancet and test strip reduces waste of the body fluidsample by accurately transferring the sample from the lancet to the teststrip.

Another concern of users of multiple disposable units is the preferencefor smaller body fluid sample sizes that are used for testing,preferably a volume less than 1 microliter. Typically, a small bodyfluid sample requires a small penetration depth by the lancet whichreduces the amount of pain for the user during lancing. Further, it isdesirable that there is minimal or very little waste of body fluid fromthe lancet that is transferred to the test strip. Unnecessary waste ofbody fluid during the transfer of the body fluid from the lancet to thetest strip can result in inaccurate test results or the need for largerbody fluid samples to yield an accurate test result. There is a need fora multiple disposable unit that reduces the amount of pain for the userduring lancing by using a lancet having a small penetration depth.Moreover there is a need for a multiple disposable unit that alsoefficiently transfers the small body fluid sample from the lancet to thetest strip to eliminate any waste of body fluid.

A precise lancing profile for a lancet in an integrated disposablecartridge ensures an appropriate amount of a body fluid sample iscollected during lancing the skin or tissue. A precise lancing profilefor a lancet also ensures that an appropriate number of capillaries arecut during lancing the skin or tissue. For example, if too fewcapillaries are cut then the body fluid sample may not be large enoughto yield accurate test results. If too many capillaries are cut then anoverly large body fluid sample is collected and the user may experiencea greater amount of pain than was necessary to obtain an adequate bodyfluid sample. Various configurations of the lancet and lancet entry havebeen used to attempt to solve these concerns. One configuration is asubstantially straight lancet with a straight entry. One concern with astraight lancet having a straight entry is the deep penetration depth ofthe lancet which results in many capillaries being cut and a greateramount of pain for the user. Another configuration is a curved lancetwith a rotational entry which can also result in an overly large woundand fluid sample and unnecessary pain for the user.

Thus, there is a need for improvement in this field.

SUMMARY

One aspect concerns an integrated cartridge assembled by dropping orplacing the components into a frame. The integrated cartridge includes atest ring having a continuous strip of chemistry such that the test ringis sectionable into a plurality of test sections when the test ring ispositioned in the frame. The integrated cartridge also includes a lancetwheel having a lancet rim with a plurality of lancets extending radiallyinward from the lancet rim. Each of the lancets has a leg portion, acontact portion to contact the test section and to deposit a body fluidsample on the test section, and a lancet tip extending substantiallytransverse to the leg portion. The integrated cartridge includes a framehaving an egg crate shape with a plurality of chambers to facilitatedrop-in assembly of the lancet wheel and the test ring onto the frameand to section the test ring into the plurality of test sections suchthat each of the lancets is positioned next to one test section in theframe.

Another aspect concerns a method of assembling an integrated disposablecartridge. The method includes assembling an integrated disposablecartridge by dropping a lancet wheel onto a frame. The lancet wheel hasa rim with a plurality of radially inwardly extending lancets and theframe has a plurality of spokes defining a plurality of chambers. Eachof the lancets is positioned in one of the chambers.

Another aspect concerns a method of automatically collecting a bodyfluid sample with a lancet and transferring the body fluid sample to atest strip. An integrated disposable cartridge includes a frame, alancet wheel having a plurality of lancets extending radially inwardfrom a rim, and a test ring having a plurality of test sections, whereinthe plurality of lancets contact the plurality of test sections. Next,an incision in tissue is formed with one of the lancets by rotating thelancet away from the plurality of test sections. A body fluid sample iscollected with a capillary groove on the lancet, and the lancet iswithdrawn from the incision in tissue by rotating the lancet towards theplurality of test sections. The body fluid sample in the capillarygroove on the lancet is transferred to one of the test sections bycontacting the test section with the lancet to release the body fluidsample.

Yet another aspect concerns a microsampler wheel. The microsampler wheelincludes a base, a plurality of lancets, and a plurality of ribs. Theplurality of ribs and the plurality of lancets extend radially outwardfrom the base, and the plurality of ribs and the plurality of lancetsalternate with each other. Each of the lancets includes a curved lancettip configured to form an incision in skin. Each of the lancets is alsoconfigured to rotate about the base such that the curvature of therotation of the lancet is similar to the curvature of the lancet tip.Each of the plurality of ribs is positioned as a reference plane fordetermination of the penetration depth of the lancet tip.

Further forms, objects, features, aspects, benefits, advantages, andembodiments will become apparent from a detailed description anddrawings provided herewith.

BRIEF DESCRIPTION OF DRAWINGS

FIG. 1 is an exploded perspective view of an integrated disposablecartridge.

FIG. 2 is a top perspective view of the FIG. 1 cartridge.

FIG. 3 is a bottom perspective view of a lancet wheel that isincorporated into the FIG. 1 cartridge.

FIG. 4 is a top view of the FIG. 3 lancet wheel.

FIG. 5 is a side view of the FIG. 3 lancet wheel.

FIG. 6 is an enlarged, cross-sectional view of the FIG. 1 cartridge.

FIG. 7 is a perspective view of a frame used in the FIG. 1 cartridge.

FIG. 8 is a bottom perspective view of the FIG. 1 cartridge loaded in alancet driver mechanism.

FIG. 9 is a cross-sectional view of the FIG. 8 mechanism.

FIG. 10 is a top perspective view of the FIG. 8 mechanism thatincorporates a lancing cap.

FIG. 11 is an exploded perspective view of an integrated disposablecartridge as viewed from the top of the integrated disposable cartridge.

FIG. 12 is an exploded perspective view of the FIG. 11 integrateddisposable cartridge as viewed from the bottom of the integrateddisposable cartridge.

FIG. 13 is a top perspective view of a lancet wheel and a test ring thatare incorporated into the FIG. 11 cartridge.

FIG. 14 is a top perspective view of a lancet wheel and a test ring thatare incorporated into the FIG. 11 cartridge.

FIG. 15 is a top perspective view of a lancet wheel, a cover barrier,and a driver that are incorporated into the FIG. 11 cartridge.

FIG. 16 is a top perspective view of a lancet wheel, a cover barrier,and a driver that are incorporated into the FIG. 11 cartridge.

FIG. 17 is a side view of the FIG. 16 lancet wheel, cover barrier, anddriver.

FIG. 18 is a top view of a cover barrier in a closed position.

FIG. 19 is a top view of the FIG. 18 cover barrier in an open position.

FIG. 20 is a top perspective view of a microsampler wheel according toanother embodiment.

FIG. 21 is a cross-sectional view of the FIG. 20 microsampler wheel.

FIG. 22 is a cross-sectional view of the FIG. 20 microsampler wheelincluding a testing element.

FIG. 23 is a front partial view of the FIG. 22 lancet and capillary.

FIG. 24 is a cross-sectional view of the microsampler wheel including atesting element positioned near a lancet tip according to anotherembodiment.

FIG. 25 is a front partial view of the FIG. 24 lancet and capillary.

FIG. 26 is a cross-sectional view of the microsampler wheel including atesting element positioned near a lancet tip according to anotherembodiment.

FIG. 27 is a front partial view of the FIG. 26 lancet and capillary.

FIG. 28 is a top perspective view of a microsampler wheel according toanother embodiment.

FIG. 29 is a top perspective view of the FIG. 28 microsampler wheel.

FIG. 30 is a top perspective view of the FIG. 28 microsampler wheel.

FIG. 31 is a top perspective view of the FIG. 28 microsampler wheel.

FIG. 32 is a top perspective view of the FIG. 28 microsampler wheel.

FIG. 33 is an exploded perspective view of an integrated disposablecartridge as viewed from the top of the integrated disposable cartridge.

FIG. 34 is a bottom perspective view of a test ring and a test ringframe that is incorporated into the FIG. 33 cartridge.

FIG. 35 is a top perspective view of the FIG. 33 integrated disposablecartridge.

FIG. 36 is a bottom perspective view of the FIG. 33 integrateddisposable cartridge.

FIG. 37 is a perspective view of a driver that is incorporated into across-sectional view of the FIG. 33 integrated disposable cartridge.

FIG. 38 is a side view of the FIG. 37 mechanism.

FIG. 39 is a perspective view of the FIG. 37 mechanism with the driverin a partially actuated position.

FIG. 40 is a perspective view of the FIG. 37 mechanism with the driverin a fully actuated position.

FIG. 41 is a top perspective view of a lancet frame, lancet wheel, andtest ring according to another embodiment.

FIG. 42 is a perspective view of the FIG. 41 mechanism that depicts alancet in an initial position.

FIG. 43 is a perspective view of the FIG. 42 mechanism that depicts thelancet in a fully actuated position.

FIG. 44 is a perspective view of the FIG. 42 mechanism that depicts thelancet in a final position.

FIG. 45 is a perspective view of a lancet frame, lancet wheel, and testring according to another embodiment that depicts a lancet in an initialposition.

FIG. 46 is a perspective view of the FIG. 45 mechanism that depicts thelancet in a fully actuated position.

FIG. 47 is a perspective view of the FIG. 45 mechanism that depicts thelancet in a final position.

FIGS. 48, 49, 50, 51, 52, and 53 are schematical representations ofvarious techniques of actuating a lancet and transferring the body fluidsample to a test section.

FIG. 54 is a perspective view of a portable meter system according toone embodiment.

FIG. 55 is a top view of a lancet frame, lancet wheel, and test ringloaded in the FIG. 54 mechanism with the lid open.

FIG. 56 is a top perspective view of the FIG. 54 mechanism with the topcover removed.

FIG. 57 is a bottom perspective view of the FIG. 56 mechanism with thetop and bottom covers removed.

FIG. 58 is a bottom perspective view of the FIG. 57 mechanism with thelower printed circuit board removed.

FIG. 59 is a partial top perspective view of the FIG. 58 mechanism withthe upper printed circuit board removed.

FIG. 60 is a partial top perspective view of the FIG. 59 mechanism.

FIG. 61 is a partial top perspective view of the FIG. 60 mechanism withthe release arm removed.

FIG. 62 is a partial top view of the FIG. 61 mechanism.

FIG. 63 is a partial exploded bottom view of the FIG. 62 mechanism.

FIG. 64 is a bottom perspective view of the upper printed circuit board,lower printed circuit board, and battery.

FIG. 65 is a top perspective view of the display, upper printed circuitboard, lower printed circuit board, and battery.

FIG. 66 is a top perspective view of the FIG. 61 mechanism with theframe and lancet frame removed.

FIG. 67 is a partial top perspective view of the FIG. 59 mechanism.

FIG. 68 is a partial top perspective view of the FIG. 59 mechanism.

FIG. 69 is a partial top perspective view of the FIG. 59 mechanism.

FIG. 70 is a perspective view of crank shaft, crank, tip up link,dampener, spring motor, fourth gear, and priming gear.

FIG. 71 is a perspective view of a portable meter system according toone embodiment.

FIG. 72 is a partial top perspective view of the FIG. 71 mechanism withthe top and bottom covers removed in an initial position.

FIG. 73 is a partial top perspective view of the FIG. 71 mechanism withthe top and bottom covers removed in an initial position of a shallowpenetration depth setting.

FIG. 74 is a partial top perspective view of the FIG. 71 mechanism withthe top and bottom covers removed in a fully extended position of ashallow penetration depth setting.

FIG. 75 is a partial top perspective view of the FIG. 71 mechanism withthe top and bottom covers removed in a final position of a shallowpenetration depth setting.

FIG. 76 is a partial top perspective view of the FIG. 71 mechanism withthe top and bottom covers removed in an initial position of a deeppenetration depth setting.

FIG. 77 is a partial top perspective view of the FIG. 71 mechanism withthe top and bottom covers removed in a fully extended position of a deeppenetration depth setting.

FIG. 78 is a partial top perspective view of the FIG. 71 mechanism withthe top and bottom covers removed in a final position of a deeppenetration depth setting.

FIG. 79 is a partial top perspective view of the FIG. 76 mechanism.

FIG. 80 is a partial top perspective view of the FIG. 73 mechanism withthe bottom cover.

FIG. 81 is a partial top perspective view of the FIG. 76 mechanism withthe bottom cover.

FIG. 82 is a perspective view of a trigger system.

FIG. 83 is a perspective view of the FIG. 82 mechanism.

FIG. 84 is a perspective view of the FIG. 82 mechanism.

FIG. 85 is a perspective view of the FIG. 82 mechanism.

FIG. 86 is a top perspective view of a hand held measuring apparatus forblood glucose tests with an inserted disk-like cartridge.

FIG. 87 is a cross-sectional view of the FIG. 86 cartridge with aportion of a sealing foil removed.

FIG. 88 is a cross-sectional view of the FIG. 86 mechanism.

FIG. 89 is a view of the FIG. 88 mechanism with the sampling member in afully actuated position.

FIG. 90 is a view of the FIG. 88 mechanism with the sampling member in apartially retracted position.

FIG. 91 is a view of the FIG. 88 mechanism with the sampling member in afully retracted position and a transfer initiating position.

DESCRIPTION OF SELECTED EMBODIMENTS

For the purpose of promoting an understanding of the principles of theinvention, reference will now be made to the embodiments illustrated inthe drawings and specific language will be used to describe the same. Itwill nevertheless be understood that no limitation of the scope of theinvention is thereby intended. Any alterations and further modificationsin the described embodiments, and any further applications of theprinciples of the invention as described herein are contemplated aswould normally occur to one skilled in the art to which the inventionrelates. One embodiment of the invention is shown in great detail,although it will be apparent to those skilled in the relevant art thatsome features that are not relevant to the invention may not be shownfor the sake of clarity.

Any directional references in this detailed description with respect tothe Figures, such as up or down, or top or bottom, are intended forconvenience of description, and by itself does not limit the presentinvention or any of its components to any particular positional orspatial orientation.

One embodiment concerns a unique integrated disposable cartridge or discas well as a technique for inexpensively manufacturing the cartridge ordisc, which is by virtue of the design. The unique cartridge utilizes aunique “drop-in” or “modular” design that allows a plurality of lancetson a lancet wheel to be aligned in sample chambers of a disc-shapedframe. This unique drop-in design eliminates the need for individualalignment and placement of the plurality of lancets. A test ring is alsopositioned on the frame such that the sample chambers form a pluralityof test elements on the test ring. As should be appreciated, the lancetwheel, frame, and test ring are manufactured separately and assembled toform an integrated disposable cartridge. In one form, the lancet wheel,frame, and test ring are sterilized after assembly of the cartridge. Inanother form, the lancet wheel, frame, and test ring are sterilizedindividually. One or more sealing foils or sheets positioned on theexterior of the cartridge maintain the sterility of the lancets andhumidity of the test elements prior to lancing the skin or tissue. Thecartridge protects other persons from unintended contact of used lancetsafter lancing the skin or other tissue. The cartridge includesindividual, separate chambers to maintain the humidity of the chemistryon each of the test elements prior to lancing the skin or tissue. Theunique shape of the lancets and the placement of the test elements onthe frame enable automatic transfer of a body fluid sample from thecapillary of the lancet to a test element immediately after a lancingand sampling cycle has occurred. The automatic transfer of the bodyfluid sample enables a “one step” operation of lancing, sampling, andtesting of the body fluid sample. Moreover, the lancet is configured tocollect a small volume of body fluid, such as less than 0.1 microliter,and transfer this small volume to the test section for analysis withoutconsiderable loss of fluid. As should be appreciated, the one stepoperation and small size of the cartridge and associated meter providesfor on-the-go convenience for users.

A second embodiment also concerns a unique integrated disposablecartridge or disc as well as a technique for inexpensively manufacturingthe cartridge or disc. The cartridge in this embodiment utilizes aunique lancet wheel design that includes a plurality of microneedles orlancets that alternate with a plurality of ribs. The cartridge includesa test element disc that has a plurality of test elements positionednext to the plurality of lancets. The lancet wheel and the test elementdisc are manufactured separately and assembled together to form thecartridge. Together the lancet wheel and the test element disc define aplurality of individual lancing and testing events. The lancets have aunique built-in spring shape and the lancet tip forms a slight circularpath during lancing. The unique shape of the lancets provides that thelancets spring back or return to their original pre-incision positionafter lancing the skin or tissue. Moreover, each of the plurality oflancets includes a curved lancet tip corresponding to the curvature ofthe circular path traced by the lancet tip during the bending andretraction during a lancing cycle of the lancet. The curved shape of thelancet matching a curved trajectory path mimics the straight line motiontypical in most common lancing systems. A drive mechanism that forcesthe lancet tip to follow a curved path during penetration and retractionfollows the natural bending or flexing of the lancet arm's radius lengthand enhances simplicity of design and manufacture of the disposable. Asshould be appreciated, the return of the contaminated lancet to thepre-incision or un-flexed position protects other persons fromaccidentally contaminating themselves with a used lancet. Each of thelancet tips includes a micro-capillary sized to collect a body fluidsample via capillary action. The capillary is positioned on the front orrear face of the lancet tip, and the capillary can extend variouslengths from the lancet tip along the lancet. The plurality of testelements is positioned next to the capillaries on the lancets such thatas the lancet tip returns to its pre-incision position, the body fluidsample in the capillary is transferred from the capillary to the testelement.

A cartridge 20 according to one embodiment is illustrated in FIGS. 1 and2. The cartridge 20 is configured to lance skin to form an incision,collect a body fluid sample from the incision, analyze the body fluidsample, and be indexed for a subsequent lancing. The cartridge 20 formsa sterile environment for a plurality of lancets and a plurality of testelements, and the cartridge 20 maintains the low humidity of thechemistry independently for each of the plurality of test elements priorto lancing the skin or tissue. The individual elements or modularcomponents of the cartridge 20 are manufactured separately and assembledinto the final form. For example, in one embodiment, the cartridge 20includes twenty-five or more lancing and testing modules by assemblingfive or six components to form cartridge 20. Moreover, there is no userinput required to transfer the body fluid sample from the lancet to thetest strip as the cartridge 20 performs this task automatically after anincision in skin is formed. The cartridge 20 also stores the usedlancets and test elements after lancing and testing to prevent metercontamination and/or cross contamination between the individual lancetsand test elements contained in the cartridge 20. As shown, the cartridge20 is in the shape of a disc or circle that enables indexing by rotationof the cartridge 20 and minimizes the size of cartridge 20 when it isstored in a meter. It should be appreciated that the cartridge 20 canhave a different overall shape in other embodiments. For example, thecartridge 20 can be oval, square, or rectangular, to name a few shapes.

The cartridge 20 includes a lancet wheel 22 with a plurality of lancets24 for lancing the skin and collecting the body fluid sample and a testring 26 having a continuous test area that is divided into a pluralityof test sections 28 for analyzing the body fluid sample when the testring 26 is assembled to a frame 30. The cartridge 20 also includes aframe 30 that defines a plurality of chambers or compartments 32 forstoring the individual lancets 24 in a sterile manner. As described inmore detail below, the cartridge 20 can include a breachable sterilitysheet 40 to seal the individual lancets 24. The plurality of chambers 32aligns each of the test sections 28 with an individual lancet 24. Theframe 30 is similar to an egg crate design that allows for quickassembly of the lancet wheel 22 with the frame 30 with drop-in ormodular design of the lancet wheel 22 into the plurality of compartments32. The frame 30 also defines a plurality of openings 34 sized toreceive a driver 36. Each of the chambers 32 aligns with one of theopenings 34 on the frame 30. The driver 36 is sized and configured toextend through one of the openings 34 and into the corresponding one ofthe chambers 32 to engage and move the lancet 24 to form an incision inskin. The driver 36 can be semi or fully automatic in function, and thedriver 36 can be part of an indexing and/or actuation system asdescribed below. The driver 36 includes a sharp or pointed end to piercethrough a second sterility sheet 40 placed over the openings 34, asdescribed below. The cartridge 20 includes a first sterility sheet 38positioned to cover and seal one side of the plurality of chambers 32 offrame 30. The cartridge 20 also includes a second breachable sterilitysheet 40 positioned to cover and seal the plurality of openings 34 ofthe frame 30. The test ring 26 is configured to cover and seal theremaining side of the plurality of chambers 32 of frame 30. Thecombination of the first sterility sheet 38, the second sterility sheet40, and the test ring 26 over the plurality of chambers 32 and theplurality of openings 34 maintains the sterility of the plurality oflancets 24 and controls the humidity to which the plurality of testsections 28 are subjected. Example materials for the first sterilitysheet 38 and the second sterility sheet 40 include plastic, metal,paper, and/or other materials. In one embodiment, the first sterilitysheet 38 and the second sterility sheet 40 are each made ofaluminum-coated polyethylene terephthalate having a thickness of lessthan 12 micrometers. Furthermore, in this embodiment, the test ring 26is made of polyethylene-coated polyethylene terephthalate having athickness of less than 125 micrometers. As should be appreciated, thefirst sterility sheet 38, the second sterility sheet 40, and the testring 26 can be made of other materials.

As illustrated in FIGS. 3, 4, 5, and 6, the lancet wheel 22 includes alancet rim 23 with the plurality of lancets 24 extending radiallyinwardly from the lancet rim 23. In other words, the plurality oflancets 24 extend from the lancet rim 23 towards the center of thelancet wheel 22.

Each of the lancets 24 has a flexible leg portion 42, a contact portion44, and a lancet tip 46. The leg portion 42 is substantially straight;however, in another form, the leg portion 42 may be curved or bent orotherwise designed to provide a spring-like link. The leg portion 42extends from the lancet rim 23 to the contact portion 44. The contactportion 44 forms a first angle θ between the leg portion 42 and thelancet tip 46 as shown in FIG. 6. In one embodiment, the first angle θis approximately a 90 degree angle. In other embodiments, the firstangle θ may be another angle between 0 and 270 degrees. The lancet 24 isconfigured such that the contact portion 44 is positioned to contact onetest section 28. The leg portion 42 forms a second angle β with the edgeof a wall 50 of the frame 30, as described in more detail below. Asshown in FIG. 6, the second angle β is an acute angle.

The lancet tip 46 defines a capillary groove 48 sized to draw a bodyfluid sample via capillary action and to collect the body fluid sample.In one embodiment, the capillary groove 48 is coated with a hydrophilicmaterial to enhance the capillary action of the groove 48. The capillarygroove 48 may be located on either the front side or the back side ofthe lancet tip 46. The capillary groove 48 may be an open, closed, orcombination open and closed capillary in which to draw the body fluidsample. Typically, the capillary groove 48 is located on the inside faceof the lancet tip 46 and is an open capillary. As should be appreciated,an open capillary is easier to manufacture because the open capillarycan be easily formed. For example, the open capillary can be formed byetching the surface of the lancet tip 46 and removing material to createthe open capillary. Moreover, an open capillary groove collects bodyfluid that is drawn from beneath the skin surface below the incision.The capillary groove 48 extends from the lancet tip 46 into the contactportion 44 such that as the contact portion 44 contacts the test section28, the body fluid sample contained in the capillary groove 48 isreleased by fluid contact onto the test section 28. The capillarygrooves 48 in the plurality of lancets 24 may be manufactured bystamping, etching, carving, or combinations thereof including othertechniques.

The lancet wheel 22 having the plurality of lancets 24 can bemanufactured from a single piece of material, such as metal, plastic, orcombinations thereof including other materials. In one embodiment, thelancet wheel 22 is formed by etching, stamping, or laser cutting a metalplate and removing portions of the metal plate to expose the pluralityof lancets 24. The capillary grooves 48 are formed by etching, lasercutting, or forming the plurality of lancet tips 46 to expose thecapillary grooves 48 either simultaneously with the formation of theplurality of lancets 24 or subsequent to the formation of the lancets24. Each of the plurality of lancets 24 is bent at the contact portion44 to form the first angle θ and each of the plurality of lancets 24 isbent at the rim 23 to form the second angle β. Each of the plurality oflancets 24 radiates from the rim 23 to the center of the lancet wheel22. In another embodiment, the lancet wheel 22 can be manufactured byattaching the plurality of lancets 24 to the rim 23. It should beappreciated in other embodiments, the lancet wheel 22 is formed by othermanufacturing techniques.

As mentioned previously and illustrated in FIG. 1, the test ring 26includes the plurality of test sections 28 for testing body orbiological fluids, such as blood, interstitial fluid, as well as otherfluids, from the incision. The test section 28 for the embodiment ofFIGS. 1 and 2 will be described with reference to an optical test strip,but it should be recognized that the test section 28 can analyze bodyfluid samples in other manners, such as via amperometry, coulometry, orreflectance photometry, to name a few techniques. As should berecognized, the optical test strip can be analyzed via a charge-coupleddevice (CCD) and/or color-capture device, and a histogram reader can beused to display the test results.

In the illustrated embodiment, the plurality of test sections 28 is inthe form of a continuous strip or ring of chemistry mounted on orapplied to a film. In FIG. 1, the test ring 26 includes index lines 29printed on it to distinguish the individual test sections 28; however,in other embodiments the index lines 29 are optional. Each of the testsections 28 is located in one of the chambers 32 and positioned adjacentto and/or in contact with the contact portion 44 of one of the lancets24. Friction or rubbing between the contact portion 44 of the lancets 24and the test sections 28 prior to a lancing and testing event can damagethe chemistry on the test sections 28 and affect the analysis of thebody fluid sample. In this embodiment, the plurality of test sections 28include a thin, soluble layer to protect the chemistry on the pluralityof test sections 28 and to prevent testing errors from the friction orrubbing of the contact portion 44 of the lancet 24 with the chemistry onthe plurality of test sections 28 prior to a lancing and testing event.This thin, soluble layer does not interfere with the chemistry or affectthe analysis results of the body fluid sample during a lancing andtesting event. In another embodiment, each of the test sections 28 doesnot contact the contact portion 44; instead a breakable tab 49 ispositioned between the lancet 24 and the test section 28 to elevate thecontact portion 44 away from the test section 28. The breakable tab 49remains in position until the driver 36 engages the leg portion 42 ofthe lancet 24. The test ring 26 is configured to cover and seal one sideof the frame 30 and the corresponding side of the plurality of chambers32. In one embodiment, the test ring 26 includes a chemistry lot codingin a bar code or radio frequency identification (RFID) chip to storeinformation on the calibration for the chemistry lot in a convenientformat for the plurality of test sections 28.

As illustrated in FIGS. 1, 2, and 7, the frame 30 includes a pluralityof spokes or walls 50 configured to define the plurality of chambers 32in which each of the chambers 32 is sized to house one of the lancets24. The plurality of walls 50 segregate the plurality of lancets 24 andmaintain the sterility of the plurality of lancets 24. Moreover, sincethe lancets 24 return to their original pre-incision forming position inthe chambers 32, the plurality of walls 50 prevent contamination ofsterile lancets 24 by preventing contact between used and unused(sterile) lancets. The frame 30 is circular in shape, and each of thechambers 32 is a trapezoidal or wedge-like shape. In one form, the frame30 is approximately 38 millimeters diameter, 3-5 millimeters height, andincludes twenty-five chambers to store twenty-five of the lancets 24 andtwenty-five of the test sections 28. In other forms, the frame 30 andthe chambers 32 may be shaped differently. For example, the frame 30and/or the chambers 32 can have a rectangular, oval, and/or triangularshape.

As illustrated in FIGS. 2 and 7, the frame 30 also includes a pluralityof internal gears 52 located near the center of the frame 30. Each ofthe internal gears 52 is positioned near one of the chambers 32. Theplacement of the gears 52 next to the chambers 32 enables a spindle orother engagement mechanism to engage the gears 52 and rotate the frame30 to position a subsequent chamber 32 and corresponding opening 34 inline with the driver 36. The gears 52 may be positioned at otherlocations on the frame 30, and the gears 52 may be configureddifferently to engage other rotational mechanisms in other embodiments.Each of the plurality of internal gears 52 is triangular in shape;however, in other embodiments the plurality of internal gears 52 may beshaped differently. For example, the plurality of internal gears 52 canhave a circular, rectangular, and/or oval shape. In another example, theplurality of internal gears 52 index the cartridge 20 to provide onlyone way in which to insert the cartridge 20 into a meter 66, asdiscussed below.

The frame 30 also includes a frame rim 53 on the exterior, and a hub 54on the interior, as illustrated in FIGS. 2 and 7. The frame rim 53defines the plurality of openings 34 such that each of the openings 34corresponds with one of the chambers 32. Each of the openings 34 iscircular in shape; however, in other embodiments the openings 34 may beshaped differently. For example, each of the openings 34 can have anoval, elliptical, and/or rectangular shape, to name a few shapes. Inanother example, each of the openings 34 is open to the bottom of theframe 30 to provide for easier molding of the frame 30. Moreover, eachof the openings 34 is sized to receive the driver 36. The hub 54 iscircular in shape for mounting the frame 30 onto a spindle or otherrotatable mechanism. The hub 54 can be shaped differently in otherembodiments.

In one embodiment, the frame 30 is constructed from desiccant-filledplastic which is injection molded into a disc shaped frame. In otherembodiments, the frame 30 can be made from other materials such asmetal, wood, ceramic, plastic, other materials, and/or compositesthereof. In another embodiment, the frame 30 includes a separatedesiccant wedge or desiccant granules added to each of the chambers 32.Moreover, the frame 30 can be constructed from other techniques such asattaching the plurality of walls 50 and the plurality of internal gears52 to the hub 54 by gluing, welding, or some other mechanism forattachment. In one form, frame 30 is sterilized using an inline electronbeam (e-beam) sterilization process. The frame 30 can be sterilized inother manners, such as via gamma radiation or ultraviolet sterilizationtechniques. Moreover, frame 30 can also be sterilized at any one of thevarious assembly stages.

As illustrated in FIGS. 8, 9, and 10, the cartridge 20 is loaded into ameter 66. The meter 66 can be configured to display the analysis resultsof the body fluid sample. The meter 66 includes an actuation mechanism60. In one embodiment, the actuation mechanism 60 engages and moves thedriver 36 to engage one of the lancets 24. In another embodiment, theactuation mechanism 60 indexes the frame 30 to position the driver 36adjacent the opening 34 of an unused lancet 24. As should beappreciated, in one embodiment, the actuation mechanism 60 engages andmoves the driver 36 and the actuation mechanism 60 also indexes theframe 30. The meter 66 is not shown in its entirety, but it should beappreciated the meter 66 covers and encloses the cartridge 20, thedriver 36, and the actuation mechanism 60. The meter 66 can be variousshapes such as rectangular, triangular, circular, and/or oval, to name afew shapes. The meter 66 can be made of various materials, such asplastic, metal, and/or other materials.

In the embodiment illustrated in FIG. 10, the meter 66 includes alancing cap 62 that is placed against the incision during lancing. Thelancing cap 62 defines an incision location opening 64. As should beappreciated, the user places the appropriate body part that is to belanced over the incision location opening 64 and the lancing tip 46passes through the incision location opening 64 to form an incision inthe user. The lancing cap 62 forms a tapered circular shape but can beshaped differently in other embodiments. For example, the lancing cap 62can be pyramidal, U-shaped, ovoidal, circular, or some other shape. Theincision location opening 64 is also circular in shape but can be shapeddifferently in other embodiments. The lancing cap 62 can be made ofvarious materials, such as plastic, metal, and/or other materials.

In one embodiment, the lancing cap 62 is configured to adjust thepenetration depth of the lancing tip 46. In one example, the lancing cap62 is threaded into the meter 66. The threaded engagement allows thelancing cap 62 to move relative to the meter 66 in order to control thepenetration depth of the lancing tip 46.

In another embodiment, the lancing cap 62 is configured to detect aforce required by the user to initiate lancing. The lancing cap 62 canalso control the skin deflection thru the lancing cap 62 to a knownvariation or depth. Further, the lancing depth can be controlled by theamount of travel of the driver 36 to engage the lancet 24 in which therange of motion of the driver 36 is set by the user. Additionally, thedriver 36 may move in a linear radial motion, a rotational motion withan eccentric shape, or a tipping motion to lift up and down the flexibleleg portion 42.

To use the cartridge 20, a user positions a body part to be lanced, mostlikely a finger, over the incision location opening 64. The driver 36 isactuated to pierce through the second sterility sheet 40, pass throughthe corresponding opening 34, and enter the chamber 32. The driver 36continues moving into the chamber 32, and the driver 36 engages the legportion 42 of the active lancet 24. As the driver 36 engages the legportion 42, the driver 36 applies a force to the leg portion 42 to movethe lancet tip 46 in a direction orthogonal to the frame 30. As thelancet tip 46 moves, the lancet tip 46 pierces through the firststerility sheet 38 and continues into the skin of the user that has beenplaced over the incision location opening 64. In one embodiment, as thelancet tip 46 forms an incision, the body fluid sample from the incisiontravels along the capillary groove 48 via capillary action towards thecontact portion 44 and the capillary groove 48 collects the body fluidsample from the incision while the lancet tip 46 is in the skin of theuser. After the driver 36 reaches its maximum extension position, thedriver 36 stops and reverses its path of movement. As the driver 36reverses its path of movement, the force applied to the leg portion 42is reduced and the lancet tip 46 withdraws from the incision. In anotherembodiment, the capillary groove 48 collects the body fluid sample whilethe lancet tip 46 returns to its original position in the chamber 32, asdescribed next. As the driver 36 continues to reverse its direction oftravel, the motion may be slowed down to allow enough time for thelancet tip 46 to fill the capillary groove 48 before the lancet tip 46returns to its original position in the chamber 32. Due to the resilientnature of each lancet 24, the lancet tip 46 springs back to its originalposition in the chamber 32 on its own. In one embodiment, if the firstincision formed by the lancet tip 46 is too shallow in depth to providean adequate amount of body fluid sample for the test section 28 to yieldaccurate test results, then the lancet tip 46 can form a second incisionin skin as described above before the actuation mechanism 60 rotates theframe 30. In its final resting position, the contact portion 44 of theactive lancet 24 contacts the test section 28 and the body fluid sampleis released from the capillary groove 48 onto the test section 28 bypreferential capillarity between the contact portion 44 of the lancet 24and the chemistry on the test section 28. The lancet 24 remains in itsfinal resting position with the contact portion 44 resting against thetest section 28. For the next test, the actuation mechanism 60 rotatesthe frame 30 via internal gears 52 or another index mechanism. Theactuation mechanism 60 retracts the driver 36 and rotates the frame 30so as to align the next corresponding opening 34 and the next unused orsterile lancet 24 with the driver 36.

A cartridge 120 according to one embodiment is illustrated in FIGS. 11,12, 13, 14, 15, 16, 17, 18, and 19. The cartridge 120 is similar tocartridge 20; therefore for the sake of brevity features from thecartridge 120 that are similar to the cartridge 20 will not bediscussed. Similar to cartridge 20, cartridge 120 includes a firststerility sheet 138 positioned to cover and seal one side of a pluralityof chambers 132 of frame 130. However, cartridge 120 includes a secondsterility sheet 140 positioned to cover and seal a plurality of openings134 and the other side of the plurality of chambers 132. In anotherform, a test ring 126 and the second sterility sheet 140 are configuredto cover and seal the same side of the plurality of chambers 132. In oneembodiment, the second sterility sheet 140 is made of aluminum foilhaving a thickness of 25 micrometers and the second sterility sheet 140is heat sealed over a frame 130 to seal each of chambers 132 separately.

Lancet wheel 122 is similar to lancet wheel 22. Similar to lancet wheel22, lancet wheel 122 includes a lancet rim 123 with a plurality oflancets 124 extending radially inward from the lancet rim 123. Similarto lancet wheel 22, each of the lancets 124 includes a flexible legportion 142, a contact portion 144, and a lancet tip 146. However, thecontact portion 144 of each of the lancets 124 is curved and sized torest on a cover barrier 156 when the lancet 124 is at rest. Further thecontact portion 144 fits in a window 157 of the cover barrier 156 whenthe lancet is actuated, as described below. The spring force of flexibleleg portion 142 applies a force to the cover barrier 156 to press thecover barrier 156 against a test section 128 until the lancet 124 isactuated by a driver 136. Each of lancets 124 also defines a slot 147sized to receive a driver 136, as described in more detail below.Similar to lancet tip 46, lancet tip 146 defines a capillary groove 148.

Test ring 126 is similar to test ring 26; however, the plurality of testsections 128 is in the form of a continuous ring of chemistry mounted onor applied to a film. In one form, the chemistry coating is applied to afilm made of polyethylene terephthalate having a thickness of 250micrometers. The test ring 126 is attached to the second sterility sheet140. As illustrated in FIGS. 13 and 14, a plurality of cover barriers156 defining a plurality of windows 157 are positioned on the test ring126 under the contact portion 144 of the plurality of lancets 124. Theplurality of cover barriers 156 protect and cover the chemistry on thetest ring 126 by eliminating contact between the test ring 126 and thelancet 124 prior to actuation of the lancet 124. Moreover, each coverbarrier 156 is configured to cover one test section 128 as defined bythe plurality of index lines 129. As the lancet 124 is actuated by thedriver 136, the driver 136 slides through the slot 147 of the lancet 124and engages the cover barrier 156 to push the cover barrier 156 acrossthe test section 128 thereby positioning the window 157 over framewindow 161 (described below) and the test section 128. The driver 136also pushes the cover barrier 156 under a corresponding wedge 159 madeof desiccant material, in the illustrated embodiment. Lancet 124 formsan incision in skin and collects a body fluid sample similarly to lancet24, as described above. After the lancet 124 forms an incision andcollects a body fluid sample, the contact portion 144 contacts the testsection 128 through the window 157 and frame window 161 (describedbelow) and deposits the body fluid sample onto the test section 128.

In the illustrated embodiment, the cartridge 120 includes a plurality ofwedges 159 made of a desiccant material. Each of the wedges 159 ispositioned in each chamber 132 of the frame 130 adjacent the lancet tip146.

Frame 130 is similar to the frame 30. Frame 130 includes a plurality ofwalls 150 that define a plurality of chambers 132. Frame 130 includes anupper rim 153 that defines a plurality of openings 134. Each of theopenings 134 is connected with a corresponding chamber 132. As should beappreciated, since each of the openings 134 are connected with one ofthe chambers 132, manufacturing of frame 130 is simplified. In theillustrated embodiment, each of the openings 134 has a semi-circularshape; however, in other embodiments the openings 134 are shapeddifferently. The frame 130 also includes a lower rim 155 defining aplurality of frame windows 161 for allowing contact between the contactportion 144 of the lancet 124 and the test section 128 in which a bodyfluid sample from the contact portion 144 is transferred to the testsection 128 through the window 157 and the frame window 161. In theillustrated embodiment, the lower rim 155 is substantially flat. Inother embodiments, the lower rim 155 is curved.

In this embodiment, the frame 130 is made of polypropylene andconstructed by injection molding techniques. In other embodiments, theframe 130 is made of other material and other techniques as describedabove.

The frame 130 also includes a plurality of internal gears 152 similar tointernal gears 52. The frame 130 also includes a hub 154 on the interioror center of the frame 130. Hub 154 is similar to hub 54.

As mentioned previously, a second embodiment of an integrated disposablecartridge or disc includes a microsampler wheel 200 and a test ring orplurality of test sections 210. As should be appreciated, the lancets onthe microsampler wheel 200 and the plurality of test sections 210 areoriented in an alternative manner, as described below. One embodiment ofa microsampler wheel 200 is illustrated in FIGS. 20 and 21. Themicrosampler wheel 200 lances skin to form an incision and collects thebody fluid sample from the incision. The body fluid sample istransferred from the microsampler wheel 200 to one of the plurality oftest sections 210 where the body fluid sample is analyzed.

The microsampler wheel 200 includes a plurality of ribs 202 alternatingwith a plurality of microneedles or lancets 204. The microsampler wheel200 also includes a base 206 from which the plurality of ribs 202 andthe plurality of lancets 204 extend from and a first cylinder 208configured to drive each of the plurality of lancets 204 to form anincision in skin.

Each of the ribs 202 serves as a guide or a reference plane for anadjacent lancet 204 to determine the depth of penetration of a lancettip 226, as described below. Each of the plurality of ribs 202 is atrapezoidal shape; however, in other embodiments, each of the ribs 202may be shaped differently, such as polygonal or oval, to name a few.Furthermore, each of the plurality of ribs 202 is substantially flat,which beneficially enables the microsampler wheel 200 to form an overallcompact shape. Moreover, each of the ribs 202 serves as a referenceplane or surface from which the depth of penetration of thecorresponding lancet tip 226 can be determined.

Each of the lancets 204 includes a leg portion 220 that extends from thebase 206 towards a first leg member 222. The first leg member 222 spansbetween the leg portion 220 and a second leg member 224 of each of thelancets 204. The second leg member 224 spans between the first legmember 222 and a lancet tip 226 of each of the lancets 204. As shown inFIG. 21, the leg portion 220 extends from the base 206 and forms a firstangle α with the base 206. First angle α is an acute angle. The legportion 220 is substantially straight. The first leg member 222 forms asecond angle δ with the leg portion 220. The second angle δ is an obtuseangle, as illustrated. The first leg member 222 is substantiallystraight. The second leg member 224 forms a third angle γ with thelancet tip 226. The third angle γ is an obtuse angle. The second legmember 224 is substantially straight. In another embodiment, the firstleg member 222 and/or the second leg member 224 are curved.

As shown in FIG. 21, the lancet tip 226 is curved. The curvature oflancet tip 226 corresponds to the radius of the circular path that thelancet 204 follows during actuation and retraction of the lancet 204.Moreover, the curvature of the lancet tip 226 corresponds with thecurvature of the movement of the lancet 204 as the lancet tip 226 formsan incision in a user's skin and thereafter withdraws from the user'sskin. In another embodiment, the lancet tip 226 is straight.

Each of the lancets 204 also includes a capillary groove 228 sized todraw body fluid from an incision or skin surface via capillary action.In one embodiment, the capillary groove 228 includes a hydrophiliccoating to draw the body fluid along the capillary groove 228 towardsthe second leg member 224. The capillary groove 228 extends from thelancet tip 226 to the second leg member 224 as shown in FIGS. 22 and 23.In some embodiments, the capillary groove 228 extends from the lancettip 226 to the second leg member 224 and into the first leg member 222.As illustrated in FIGS. 22 and 23, the capillary groove 228 ispositioned on the front side of the lancet tip 226. In otherembodiments, the capillary groove 228 may be positioned on the frontside or the rear side of the lancet tip 226 corresponding to theplacement of the test section 210. The front side of the lancet tip 226corresponds to the face of the lancet 204 that is furthest away from thebase 206. The back side of the lancet tip 226 corresponds to the face ofthe lancet tip 226 that is closest to the base 206.

As shown in FIG. 23, the capillary groove 228 forms an open samplingchannel to collect a body fluid sample via capillary action. In anotherembodiment, the capillary groove 228 is enclosed. As should beappreciated, when compared to a closed capillary or channel, an opencapillary groove 228 has the advantage that the lancet 204 can beproduced more easily in an etching process. Other examples of formingthe capillary groove 228 in the lancet 204 include a sharp point, alaser beam, or other forms or mechanisms of removing material from thelancet 204 to create the open capillary groove 228. Any technique offorming the capillary groove 228 results in automatic body fluidsampling when the lancet tip 226 is positioned in skin. Additionally, anopen capillary as compared to a closed capillary more easily collectsthe body fluid sample that may be on the skin surface surrounding theincision.

As illustrated in FIG. 20, the base 206 is circular in shape. The base206 may be shaped differently in other embodiments, such as,rectangular, oval, or square. As described below, the ribs 202, thelancets 204, and the base 206 may be formed from one piece of material.In other forms, the ribs 202 and/or the lancets 204 may be manufacturedseparately and then attached to the base 206. In one embodiment, thewheel 200 is loaded into a meter configured to display the analysisresults. Further, in this embodiment, the wheel 200 is stationary andthe base 206 is attached to a housing of the meter such that the housingor exterior of the meter rotates about the wheel 200 to expose an unusedlancet 204. However, in another embodiment, the base 206 rotates aboutits center to expose an unused lancet 204 in the housing.

As illustrated in FIGS. 20 and 21, the first cylinder 208 is locatedadjacent the leg portion 220 of the lancet 204. The first cylinder 208is substantially circular in shape and rolls or rotates along the legportion 220 of the lancet 204 towards the lancet tip 226 in oneembodiment, or in another embodiment the first cylinder 208 slides alongthe surface of the leg portion 220 towards the lancet tip 226. As shouldbe appreciated, the first cylinder 208 applies a force to the legportion 220 to move the lancet 204 in a direction away from the firstcylinder 208. The movement of the lancet 204 from the force of the firstcylinder 208 causes the lancet tip 226 to follow a circular path to forman incision in a user as described previously. At the end of themovement or range of motion of the first cylinder 208, the firstcylinder 208 reverses its direction and moves toward the base 206. Inother embodiments, actuation of the lancet 204 occurs by other forms,such as a driver, a spring, or another mechanical or electricalmechanism. These other forms of actuation of the lancets 204 will alsoforce the curved lancet tip 226 to follow a circular movement. Thelancing profile of the lancet tip 226 can be traced by correlating thedistance the first cylinder 208 travels along the leg portion 220, thediameter of first cylinder 208, and the geometry of the lancet 204.

After the incision has been formed by the lancet tip 226, the lancet tip226 is removed from the skin of the user by springing back to itsoriginal pre-incision forming position and contacting one of the testsections 210 to transfer the body fluid sample to the test section 210.As the first cylinder 208 reverses its direction and moves toward thebase 206, the curvature of the lancet tip 226 ensures that as the lancettip 226 withdraws from the incision, the lancet tip 226 will follow thesame circular path that it formed during the incision. No additionalactuator is necessary to withdraw the lancet tip 226 from the incision;rather the resilient nature of the lancet 204 causes the lancet tip 226to spring back to its original position referenced by the ribs 202 asthe first cylinder 208 returns to its original position. Moreover, asthe lancet 204 springs back to its original pre-incision formingposition, the body fluid sample contained in the capillary groove 228 istransferred to the test section 210 as the second leg member 224 or thelancet tip 226 contacts the test section 210, as described below. Thelancet 204 in its original position will ensure that a subsequent useris not accidentally stuck by the contaminated lancet tip 226.

In the embodiment illustrated in FIG. 21, a second cylinder 212 ispositioned adjacent or near the first cylinder 208 to act as a stopmechanism for the first cylinder 208 during actuation of the firstcylinder 208. In the illustrated embodiment, the second cylinder 212 issubstantially circular in shape with a flat surface 230 positioned tocontact the leg portion 220. In other embodiments, the second cylinder212 may be another shape. For example, the second cylinder can be arectangular, triangular, or oval, to name a few shapes. The secondcylinder 212 forms a stop for the first cylinder 208 to limit themovement of the first cylinder 208 and the lancet 204. In anotherembodiment, the second cylinder 212 contacts the leg portion 220 duringactuation of the lancet 204 and retraction of the lancet tip 226 fromthe incision. For example, during actuation, the second cylinder 212applies a force to the leg portion 220 as the first cylinder 208 alsoapplies a force to the leg portion 220. In this embodiment, theengagement between the second cylinder 212 and the leg portion 220ensures that the lancet tip 226 is drawn slowly out of the incisionformed in the user's skin. Second cylinder 212 controls the velocity ofthe lancet tip 226 during removal of the lancet tip 226 from theincision and movement of the lancet tip 226 to its original position.The combination of the first cylinder 208 and the second cylinder 212ensures that particular prescribed lancing and velocity profiles will befollowed by the lancet tip 226. The combination of the first cylinder208 and the second cylinder 212, in one embodiment, ensures that thelancet tip 226 forms the incision rapidly and the lancet tip 226 iswithdrawn slowly from the incision. In another embodiment, the firstcylinder 208 controls the velocity of the lancet tip 226 without thesecond cylinder 212.

In one embodiment, the microsampler wheel 200 is formed from a singlepiece of material by stamping a metal plate to form the plurality ofribs 202 and the plurality of microneedles or lancets 204 and removingany excess material. In another embodiment, the microsampler wheel 200is formed from etching and bending a metal plate to form the pluralityof ribs 202 and the plurality of microneedles or lancets 204. In otherembodiments, the microsampler wheel 200 may be formed by attaching theplurality of ribs 202 and the plurality of lancets 204 to the base 206.The microsampler wheel 200 may be made of metal, such as stainlesssteel, titanium, or nickel; plastic; and/or other materials.

The plurality of test sections 210 is similar to the test sections 28described above; therefore for the sake of brevity the details are notrepeated. The plurality of test sections 210 are positioned near theplurality of lancets 204 such that one test section 210 is positionednear each capillary groove 228. The plurality of test sections 210 maybe positioned near the second leg member 224 as shown in FIG. 22, thefront of the lancet tip 226 as shown in FIG. 24, or the rear of thelancet tip 226 as shown in FIG. 26.

Reference will now be made to the various configurations of the lancet204 and the test section 210. As shown in FIG. 22, the test section 210is positioned near the second leg member 224 to analyze the body fluidsample. In this embodiment, the capillary groove 228 is positioned onthe front side of the lancet 204 as illustrated in FIG. 23. To form anincision, the first cylinder 208 rotates along the leg portion 220 andapplies a force to the leg portion 220 to rotate the lancet 204 aboutthe edge of the base 206. In the embodiment illustrated in FIG. 22, thesecond cylinder 212 applies a force to the leg portion 220 to assist thefirst cylinder 208 to rotate the leg portion 220 about the edge of thebase 206. As should be appreciated, the second cylinder 212 is optional.While the leg portion 220 rotates about the edge of the base 206, thelancet tip 226 follows a circular path to form an incision in a user.The capillary groove 228 collects a body fluid sample as the lancet tip226 forms the incision. The body fluid sample in the capillary groove228 first flows in the lancet tip 226 in a direction substantiallyparallel to the incision in skin. In this embodiment, the body fluidsample continues to flow into capillary groove 228 in the second legmember 224. As the body fluid sample flows into the second leg member224, the direction of flow changes by the third angle γ. In one form,the third angle γ is approximately 90 degrees; therefore the flow of thebody fluid sample changes direction by about 90 degrees from the lancettip 226 to the second leg member 224. The first cylinder 208 and thesecond cylinder 212 reverse their directions such that the force isremoved from the leg portion 220 and the lancet tip 226 withdraws fromthe skin. As the first cylinder 208 and the second cylinder 212 reversetheir directions, the lancet 204 springs or moves past the originalpre-incision forming position of the lancet 204 such that the second legmember 224 touches the test section 210. While the second leg member 224contacts the test section 210, the body fluid sample is transferred fromthe capillary groove 228 to the test section 210. In this embodiment,the capillary groove 228 extends into the second leg member 224 acorresponding distance such that as the second leg member 224 contactsthe test section 210, the body fluid sample in the capillary groove 228is transferred to the test section 210. The test section 210 analyzesthe body fluid sample.

As illustrated in FIGS. 24 and 25, the capillary groove 228 ispositioned on the front side of the lancet tip 226 and likewise the testsection 210 is positioned near the front side of the lancet tip 226. Thefirst cylinder 208, second cylinder 212, and the lancet 204 are similarto the embodiment described with reference to FIGS. 22 and 23, unlessdescribed differently herein. The lancet tip 226 is actuated to form anincision in skin, and the capillary groove 228 collects a body fluidsample from the incision. In this embodiment, the body fluid sampleflows in the capillary groove 228 in a direction substantially parallelto the incision in skin. After the lancet tip 226 is withdrawn from theincision in skin, the lancet 204 moves to its original pre-incisionforming position and the lancet tip 226 contacts the test section 210.As the lancet tip 226 contacts the test section 210, the body fluidsample from the capillary groove 228 is deposited onto the test section210.

In another embodiment, illustrated in FIGS. 26 and 27, the capillarygroove 228 is located on the rear side or back side of the lancet tip226. As illustrated, the lancet tip 226 can include a second capillarygroove 229 that extends from the capillary groove 228 on the rear sideof the lancet tip 226 through the lancet tip 226 to the front side ofthe lancet tip 226. With the additional capillary groove 229, the testsection 210 can be either positioned adjacent the rear side or adjacentthe front side of the lancet tip 226. The first cylinder 208, secondcylinder 212, and the lancet 204 are similar to the embodiment describedwith reference to FIGS. 22 and 23, unless described differently herein.The lancet tip 226 forms an incision in skin and the capillary groove228 collects a body fluid sample from the incision. In this embodiment,the body fluid sample flows in the capillary groove 228 in a directionsubstantially parallel to the incision in skin. In one embodiment, asthe lancet tip 226 returns to its original pre-incision formingposition, the rear side of the lancet tip 226 contacts the test section210 positioned adjacent the rear side of the lancet tip 226 and the bodyfluid sample in the capillary groove 228 is deposited onto the testsection 210. As should be appreciated, the presence of capillary groove229 ensures the body fluid sample will be deposited onto the testsection 210 whether the capillary groove 228 is located on the front orrear side of the lancet tip 226 and the test section 210 is positionedadjacent either the rear side or front side of the lancet tip 226.

A third embodiment also concerns an integrated disposable cartridge ordisc similar to the second embodiment above. The cartridge in the thirdembodiment also utilizes a unique lancet wheel design that includes aplurality of microneedles or lancets that alternate with a plurality ofribs. The lancets in this embodiment are similar to the lancets in thepreviously described embodiments. The lancets and the plurality of ribsare attached to a base in an alternating manner and configured in aninitial pre-incision forming position. The lancets and the plurality ofribs are configured to rotate about the base. A first drive mechanismforces the lancet tip to rotate about the base during penetration andretraction as the first drive mechanism presses against the lancet andthe one or more ribs adjacent the lancet. A second drive mechanismforces one or more of the ribs next to the lancet to contact skin nearthe incision location as the ribs rotate about the base and thereby forma reference plane from which the penetration depth of a lancet ismeasured relative to the adjacent one or more ribs. The position of theone or more ribs relative to the lancet allows the user to adjust thepenetration depth of the lancet independent of the actuation andmovement of the lancet. For example, the actuation and movement of thelancet is determined by pressing the first drive mechanism against theone or more ribs and the lancet while the penetration depth isdetermined by pressing the second drive mechanism against the one ormore ribs. The penetration depth of the lancet is easily adjusted as theorientation of the one or more ribs changes as determined by the seconddrive mechanism. Moreover, the unique and elegant shape of the seconddrive mechanism enables the one or more ribs to express additionalbodily fluid to the skin as the second drive mechanism presses againstand releases the one or more ribs to create a pumping action of the ribsagainst skin.

A microsampler wheel 300 according to another embodiment is illustratedin FIGS. 28, 29, 30, 31, and 32. The microsampler wheel 300 is similarto microsampler wheel 200; therefore for the sake of brevity featuresfrom the microsampler wheel 200 that are similar to the microsamplerwheel 300 will not be discussed. Similar to microsampler wheel 200,microsampler wheel 300 includes a plurality of ribs 302 alternating witha plurality of lancets 304. Also similar to the microsampler wheel 200,the microsampler wheel 300 includes a base 306 from which the pluralityof ribs 302 and the plurality of lancets 304 extend from. Each of theplurality of ribs 302 includes a first end 330 attached to the base 306and a second end 332 configured to contact skin S of a user. In thisembodiment, prior to actuation of a particular lancet 304, the pair ofribs 302 adjacent to that lancet are substantially parallel to a legportion 320 of the lancet 304. The microsampler wheel 300 also includesa first cylinder 308 and a second cylinder 312. First cylinder 308 isconfigured similar to first cylinder 208. Second cylinder 312 includes apair of cylinders or rollers positioned such that each roller contactsan individual rib 302. The rollers of second cylinder 312 straddle onelancet 304 between them such that the individual rollers of secondcylinder 312 are positioned to avoid contact with the lancet 304. Inthis embodiment, each of the individual rollers of second cylinder 312includes a curved portion 314 and a substantially flat portion 316. Inother embodiments, the second cylinder 312 may be another shape.Although not shown, in some embodiments, microsampler wheel 300 alsoincludes a plurality of test sections as previously described.

As illustrated in FIG. 28, a lancet tip 326 of one of the lancets 304 ispositioned adjacent to or in contact with skin S of a user. In theillustrated embodiment, an expression ring 400 is positioned on a fingertip; however, in other embodiments expression ring 400 is not requiredfor microsampler wheel 300 to form an incision, express a bodily fluidsample, and collect a bodily fluid sample. Moreover, the microsamplerwheel 300 is configured for use on other body parts of a user inaddition to a finger, in other words the microsampler wheel 300 isconfigured for alternate site testing. In this initial start position,substantially flat portion 316 of second cylinder 312 contacts the pairof ribs 302. In this embodiment, the pair of ribs 302 are substantiallyparallel to the leg portion 320 of the lancet 304 positioned betweenthem. In other embodiments, the pair of ribs 302 can be positionedeither above or below the lancet 304.

As illustrated in FIG. 29, second cylinder 312 is rotated such that thecurved portion 314 of second cylinder 312 contacts and presses thesecond end 332 of each of the pair of ribs 302 against skin S of theuser. The orientation of the curved portion 314 with the ribs 302facilitates rotation of second cylinder 312 to thereby adjust theorientation of the ribs 302 during lancing, expressing, and sampling.The initial contact between the pair of ribs 302 and the skin S of theuser is a skin reference position from which penetration depth of thelancet tip 326 can be measured. In some embodiments, the second cylinder312 is rotated to further press the pair of ribs 302 against skin S ofthe user to express bodily fluid to the incision site. In otherembodiments, the second cylinder 312 is rotated back and forth to causea pumping action of the pair of ribs 302 against skin S of the user tofurther facilitate expression of the body fluid to the incision site.

As shown in FIG. 30, the lancet 304 is actuated to form an incision inskin. The first cylinder 308 is pressed against the pair of ribs 302 andthe leg portion 320 of the lancet 304 to rotate the lancet 304 about thebase 306 and force the lancet tip 326 into skin S of the user. Thepenetration depth of the lancet tip 326 is determined by the geometry ofthe lancet 304, the orientation of the pair of ribs 302 against the skinS of a user, and the distance the first cylinder 308 travels along thepair of ribs 302 and/or until the first cylinder 308 contacts the secondcylinder 312. In this form, as the first cylinder 308 rolls along thepair of ribs 302 and the leg portion 320, the lancet tip 326 rotatesabout the base 306 to form an incision in skin S. As the first cylinder308 contacts the second cylinder 312, penetration of the lancet tip 326in skin S is stopped. In another embodiment, the first cylinder 308rolls along only the leg portion 320 of the lancet 304 to rotate thelancet 304 about the base 306 and force the lancet tip 326 into skin Sof the user. In yet another embodiment, the first cylinder 308 isconfigured to press against or roll along the pair of ribs 302 adjacentthe leg portion 320. In any embodiment, the lancet tip 326 follows acircular path to form an incision in skin S of the user as the lancet304 is rotated about the base 306.

As shown in FIG. 31, the lancet 304 collects the bodily fluid samplesimilarly as lancet 204 described above. However, the second end 332 ofeach of the pair of ribs 302 is pressed against the skin S. As mentionedpreviously, in another embodiment, the second cylinder 312 is rotatedback and forth to cause a pumping action of the pair of ribs 302 againstskin S of the user. This pumping action facilitates expression of thebody fluid to the incision site and sampling of the body fluid in thelancet 304.

The first cylinder 308 starts to move or roll back from the secondcylinder 312 to its initial start position as shown in FIG. 32. As thefirst cylinder 308 returns to its original position, the lancet 304rotates about the base 306 and springs back to its pre-incision formingposition. Since second cylinder 312 is configured from two rollers ormembers separated a distance, the lancet 304 springs back and travelsthrough the gap formed between the two rollers or members. As mentionedpreviously and described above, the lancet 304 contacts a test sectionto transfer the body fluid sample to the test section similarly tolancet 204. The second cylinder 312 is rotated such that the curvedportion 314 disengages from the pair of ribs 302, and the pair of ribs302 rotates about the base 306 towards their initial pre-incisionforming position. Although not illustrated, the second cylinder 312 willcontinue to rotate to its original pre-incision forming position untilthe substantially flat portion 316 contacts the pair of ribs 302.

A cartridge 420 according to one embodiment is illustrated in FIGS. 33,34, 35, 36, 37, 38, 39, and 40. As should be recognized from thesefigures, cartridge 420 shares a number of features in common withcartridge 20 illustrated in FIGS. 1, 2, 3, 4, 5, 6, and 7. Therefore forthe sake of brevity, common features from the cartridge 420 and thecartridge 20 will not be discussed. Cartridge 420 has a test ring frame480; however, cartridge 20 does not have a test ring frame. Likecartridge 20, cartridge 420 has a test ring 426; however, test ring 426is mounted to test ring frame 480 as described in more detail below.Also like cartridge 20, cartridge 420 includes a lancet wheel 422positioned in a lancet frame 430. However, lancet wheel 422 and lancetframe 430 are slightly different than lancet wheel 22 and frame 30,respectively. In one embodiment, cartridge 20 includes twenty-fivelancets 24, twenty-five test sections 28, and twenty-five chambers 32.Comparatively, in one embodiment, cartridge 420 includes fifty lancets424, fifty test sections 428, and fifty chambers 432 in which cartridge420 has an approximately 20% larger diameter than cartridge 20.

The manner in which cartridge 420 transfers a body fluid sample from alancet 424 to a test section 428 is different than cartridge 20. Asexplained below, cartridge 420 includes a lancet 424 having a lancet tip446 that forms an incision in tissue, collects a body fluid sample fromthe incision in capillary groove 448, and transfers the body fluidsample to a test section 428 as the lancet tip 446 contacts the testsection 428. In other words, the lancet tip 446 transfers the body fluidsample to the test section 428. As should be appreciated, the body fluidsample is not required to fill the entire capillary groove 448 of thelancet 424 to have a sufficiently sized sample from which to test.Moreover, since the body fluid sample is not required to fill the entirecapillary groove 448 a higher testing success rate is achieved and asmaller sized body fluid sample is needed to test with. As describedpreviously, cartridge 20 includes a lancet 24 having a lancet tip 46that forms an incision, the body fluid sample is collected in capillarygroove 48, and as the lancet returns to its original position thecontact portion 44 contacts the test section 28 to transfer the bodyfluid sample to the test section 28. In this configuration, the contactportion 44 or tail of the lancet 24 transfers the body fluid sample tothe test section 28.

Similar to cartridge 20, cartridge 420 includes a first sterility sheet438 as shown in FIG. 33. When cartridge 420 is assembled, the firststerility sheet 438 is positioned to cover and seal one side of aplurality of tester openings 482 of test ring frame 480. As mentionedabove, cartridge 420 includes a test ring frame 480. Test ring frame 480includes a plurality of tester openings 482. Each of the tester openings482 is sized to receive a lancet tip 446. Test ring frame 480 alsoincludes a plurality of windows 484 and a plurality of frame walls 485wherein each of windows 484 is positioned between a pair of frame walls485. Each of the internal windows 484 is positioned between a pair oflancet walls 434 of lancet frame 430 when the test ring frame 480 andlancet frame 430 are assembled. The placement of the windows 484 next totest sections 428 enables an optical device or other device positionedin the center of the cartridge 420 to view a corresponding test section428 through one of windows 484. In one embodiment, an engagementmechanism can engage one of the frame walls 485 and rotate the cartridge420 to position a subsequent chamber 432 of lancet frame 430 andcorresponding tester opening 482 in line with a driver 436. Each of theplurality of internal windows 484 is rectangular in shape; however, thewindows 484 may be configured differently in other embodiments. Theplurality of internal windows 484 and plurality of frame walls 485 arepositioned to receive a test ring 426.

Test ring 426 includes a plurality of index lines 429 that define aplurality of test sections 428 as illustrated in FIG. 34. The test ring426 is attached to the plurality of internal windows 484 and pluralityof frame walls 485 of the test ring frame 480 such that each of theindex lines 429 is in line with each of the lancet walls 434. Moreover,each of test sections 428 is positioned in one of the chambers 432 ofthe lancet frame 430 such that the corresponding window 484 is alignedwith one of a plurality of lancets 424.

As shown in FIGS. 33 and 37, lancet wheel 422 includes a lancet rim 423with a plurality of lancets 424 extending radially inward from thelancet rim 423. Each of the lancets 424 includes a flexible leg portion442, a contact portion 444, and a lancet tip 446. The contact portion444 of each of the lancets 424 is curved and sized to rest on one of aplurality of ledges 492 of the lancet frame 430 when the lancet 424 isat rest. Additionally, in this resting position, the lancet tip 446 doesnot contact the test section 428. Further the lancet tip 446 fits in thetester opening 482 when the lancet 424 is actuated, as described below.Each of lancets 424 also defines a slot 447 sized to receive a pointedend 437 of a driver 436, as described in more detail below. Lancet tip446 defines a capillary groove 448. Moreover, after the lancet 424 hasbeen actuated and is in a final position, the lancet tip 446 restsagainst the test section 428 such that a body fluid sample istransferred from the capillary groove 448 to the test section 428.

Lancet frame 430 in FIGS. 33, 35, and 36 is configured a littledifferent than frame 30 illustrated in FIGS. 1 and 2. Lancet frame 430in FIG. 33 includes a plurality of walls 434 that define a plurality ofchambers 432. Lancet frame 430 includes a rim 439 that is sized toreceive the plurality of frame walls 485 to position the test ring frame480 on the lancet frame 430. The lancet frame 430 also includes aplurality of ledges 492. Each of the ledges 492 is sized to receive thecontact portion 444 of the lancet 424. One of the ledges 492 ispositioned in each of the plurality of chambers 432. In the illustratedembodiment, each of the plurality of ledges 492 is substantially flat. Aplurality of openings 494 are positioned between the plurality of walls434 and the plurality of ledges 492. Each of the openings 494 is sizedto receive a driver 436. As illustrated in FIGS. 37, 38, 39, and 40,driver 436 includes a sharp or pointed end 438 to pierce through secondsterility sheet 440 placed over the openings 494, as described below.Pointed end 438 enters slot 447 of lancet 424 to actuate the lancet 424,as described below.

As shown in FIG. 33, cartridge 420 includes a second sterility sheet 440positioned to cover and seal the plurality of chambers 432 of the lancetframe 430. First sterility sheet 438, test ring 426, and secondsterility sheet 440 are configured to cover and seal the plurality oftester openings 482, the plurality of chambers 432, and the plurality ofinternal windows 484 to form an air-tight cartridge 420. Similarly,first sterility sheet 38, test ring 26, and sterility sheet 40 ofcartridge 20 are configured to form an air-tight cartridge 20.

To use cartridge 420, a user positions a body part to be lanced, mostlikely a finger, over a currently active one of the plurality of testeropenings 482. The driver 436 is actuated to pierce through the secondsterility sheet 440, pass through the corresponding opening 494, andenter the chamber 432. The driver 436 continues moving into the chamber432, and the pointed end 438 of the driver 436 engages the slot 447 ofthe active lancet 424. As the driver 436 engages the slot 447, thedriver 436 applies a force to the leg portion 442 to move the lancet tip446 in a direction orthogonal to the frame 430. As the lancet tip 446moves, the lancet tip 446 pierces through the first sterility sheet 438and continues into the skin of the user that has been placed over theactive tester opening 482. In one embodiment, as the lancet tip 446forms an incision, the body fluid sample from the incision travels alongthe capillary groove 448 via capillary action towards the contactportion 444 and the capillary groove 448 collects the body fluid samplefrom the incision while the lancet tip 446 is in the skin of the user.In one embodiment, an adequate sample size of body fluid isapproximately 90 nanoliters.

After the driver 436 reaches its maximum extension position, the driver436 stops and reverses its path of movement. As the driver 436 reversesits path of movement, the force applied to the leg portion 442 isreduced and the lancet tip 446 withdraws from the incision. Due to theresilient nature of each lancet 424, the lancet tip 446 springs back toits original position in the chamber 432 on its own. In this finalposition, the lancet tip 446 of the active lancet 424 contacts the testsection 428 and the body fluid sample is released from the capillarygroove 448 onto the test section 428 by preferential capillarity betweenthe lancet tip 446 of the lancet 424 and the chemistry on the testsection 428. The lancet 424 remains in its final resting position withthe contact portion 444 resting against the ledge 492. For the nexttest, an actuation mechanism retracts the driver 436 and rotates thetest ring frame 480 so as to align the next corresponding tester opening482 and the next unused or sterile lancet 424 with the driver 436.

A lancet frame 530, a lancet wheel 522, and a test ring 526 according toanother embodiment are illustrated in FIGS. 41, 42, 43, and 44. Asshould be recognized from these figures, the lancet frame 530 shares anumber of features in common with lancet frame 430 illustrated in FIGS.33, 35, and 36. Therefore for the sake of brevity features from thelancet frame 530 that are similar to the lancet frame 430 will not bediscussed. Unlike lancet frame 430, lancet frame 530 has a plurality ofledges 592 that are configured to retain a lancet in a flexed positionprior to actuation. Due to the resiliency of the lancet and theconfiguration of each of the ledges 592, after the lancet is releasedfrom its corresponding ledge 592, it springs back to its originalunflexed configuration and the lancet is lifted to form an incision. Inother words, the tension imposed on the lancet from the ledge 592 isreleased. After the lancet forms an incision and the lancet returns toits corresponding ledge 592, the lancet tip contacts a test section 528and transfers a body fluid sample to the test section 528. The transferof a body fluid sample from the lancet tip to a test section as comparedto the transfer of a body fluid sample from a contact portion of alancet to a test section requires less travel distance for the bodyfluid sample before the body fluid sample is transferred to a testsection. A transfer of the body fluid sample from the lancet tip ascompared to other portions of the lancet results in higher success ratesfor lancing and testing events. In some clinical trials of thisembodiment and the embodiments shown in FIGS. 33, 34, 35, 36, 37, 38,and 39, the success rate for lancet tip transfer of a bodily fluidsample to a test section was greater than 93%. In some embodiments, thetotal testing time including forming an incision, collecting a bodilyfluid sample, and analyzing the bodily fluid sample is less than 1second.

Lancet frame 530 includes a plurality of walls 534 that define aplurality of chambers 532. Lancet frame 530 also includes a plurality ofledges 592. Each of the ledges 592 is sized to receive the contactportion 544 of the lancet 524. One of the ledges 592 is positioned ineach of the plurality of chambers 532. In the illustrated embodiment,the plurality of ledges 592 is substantially rectangular. Each of theledges 592 also contains a notch 593 configured to receive the lancettip 546, as explained in more detail below. A plurality of openings 594are positioned between the plurality of walls 534 and the plurality ofledges 592. Each of the openings 594 is sized to receive a driver.

A lancet wheel 522 is positioned in the lancet frame 530 as shown inFIG. 41. Lancet wheel 522 shares a number of features in common withlancet wheel 422 illustrated in FIGS. 33 and 37. Therefore for the sakeof brevity, common features from the lancet wheel 522 and lancet wheel422 will not be discussed.

Test ring 526 is illustrated in FIG. 41. Test ring 526 shares a numberof features in common with test ring 426 illustrated in FIGS. 33 and 37.Therefore for the sake of brevity common features from the test ring 526and the test ring 426 will not be discussed. Test ring 526 includes aplurality of test sections 528. Test ring 526 is positioned on thelancet frame 530 such that each of the test sections 528 is positionedbetween a pair of walls 534 of the lancet frame 530.

In an initial position, the lancet tip 546 is positioned in the notch593 such that the contact portion 544 rests against the ledge 592 torestrain the lancet 524 from movement until a driver engages the lancet524 to release the lancet tip 546 from the notch 593. In this initialposition, each of the ledges 592 extends towards the lancet rim 523 tobend the contact portion 544 towards flexible leg portion 542. As thelancet 524 moves from the initial position to an incision formingposition, the contact portion 544 passes over both the notch 593 and theledge 592 and the lancet tip 546 moves in a direction orthogonal to thelancet frame 530. After the contact portion 544 passes over the ledge592, the contact portion 544 springs back to its original configurationdue to the resilient nature of each lancet 524. As the lancet tip 546moves, the lancet tip 546 pierces the skin of the user that has beenplaced over the corresponding chamber 532. In one embodiment, as thelancet tip 546 forms an incision, the body fluid sample from theincision travels along the capillary groove 548 via capillary actiontowards the contact portion 544 and the capillary groove 548 collectsthe body fluid sample from the incision while the lancet tip 546 is inthe skin of the user. After a driver or other mechanism reaches itsfinal extension position, the driver stops and reverses its path ofmovement. As the driver reverses its path of movement, the force appliedto the leg portion 542 is reduced and the lancet tip 546 withdraws fromthe incision. In its final position, the contact portion 544 of theactive lancet 524 rests against the ledge 592 and the bodily fluidsample is transferred from the capillary groove 548 to the correspondingtest section 528.

A lancet frame 630, a lancet wheel 622, and a test ring 626 according toanother embodiment are illustrated in FIGS. 45, 46, and 47. As should berecognized from these features, lancet frame 630 shares a number offeatures in common with lancet frame 430 illustrated in FIGS. 33, 35,and 36. Therefore for the sake of brevity, common features from lancetframe 630 and lancet frame 430 will not be discussed. As describedbelow, lancet frame 630 includes a plurality of slats 692 that areconfigured to restrain the plurality of lancets 624 such that theplurality of lancets 624 do not contact the plurality of test sections628 prior to actuation. Beneficially, the plurality of slats 692 areconfigured to force the lancet tip 646 to contact a test section andtransfer a body fluid sample to the test section after the lancet tip646 has collected a body fluid sample. As mentioned above, the transferof body fluid from the lancet tip requires less blood travel distancethan compared to the transfer of body fluid from the contact section orany other section of the lancet. Also beneficially, the plurality ofslats 692 restrains the contaminated lancets 624 after a testing event.

Lancet frame 630 includes a plurality of walls 634 that define aplurality of chambers 632 as shown in FIGS. 45, 46, and 47. The lancetframe 630 also includes a plurality of slats 692. A pair of the slats692 is positioned in each of the plurality of chambers 632. Each of theslats 692 is attached to one of the walls 634. Between each of the pairsof slats 692 is a slat opening 694. The pair of slats 692 is sized andpositioned on the walls 634 to receive the lancet tip 646 of the lancet624 in the slat opening 694 when the lancet 624 is in an initialposition. The pair of slats 692 is also sized and positioned to restrainthe lancet 624 when the lancet 624 is in its final position. After thelancet 624 has been actuated and rests in a final position, the pair ofslats 692 restrains the pair of tabs 645 between the pair of slats 692and the lancet frame 630. In the illustrated embodiment, each of theplurality of slats 692 is substantially rectangular. Each of theplurality of slats 692 forms an angle θ with each of the walls 634.Angle θ is an acute angle.

A lancet wheel 622 is positioned in the lancet frame 630 as shown inFIG. 45. Lancet wheel 622 includes a number of features in common withlancet wheel 422 as shown in FIGS. 33, 37, and 38; therefore for thesake of brevity common features from the lancet wheel 622 and the lancetwheel 422 will not be discussed. Lancet wheel 622 includes a lancet rim623 with a plurality of lancets 624 extending radially inward from thelancet rim 623. Each of the lancets 624 includes a flexible leg portion642, a contact portion 644, and a lancet tip 646. The contact portion644 of each of the lancets 624 includes a pair of tabs 645 sized to reston the pair of slats 692 of the lancet frame 630 when the lancet 624 isin an initial position. After the lancet 624 has been actuated and restsin its final position, the pair of slats 692 restrains the pair of tabs645 between the pair of slats 692 and the lancet frame 630. Each oflancets 624 also defines a slot 647 sized to receive a pointed end of adriver. In one embodiment, lancet tip 646 defines a capillary groove(not illustrated).

Test ring 626 shares a number of common features with test ring 526illustrated in FIGS. 41, 42, and 44; therefore for the sake of brevitycommon features from the test ring 626 and the test ring 526 will not bediscussed. Test ring 626 includes a plurality of test sections 628. Testring 626 is positioned on the lancet frame 630 such that each of thetest sections 628 is positioned between a pair of walls 634 of thelancet frame 630.

In an initial position, the lancet tip 646 is positioned in the slatopening 694 such that the pair of tabs 645 rest against the pair ofslats 692 to restrain the lancet 624 from movement until a driverengages the lancet 624 to move the lancet 624 and release the pair oftabs 645 from the pair of slats 692. Additionally, in the initialposition, the resiliency of the lancet 624 causes the contact portion644 to bend as the pair of tabs 645 push against the slats 692. As thedriver moves the lancet 624 from the initial position to an incisionforming position, the contact portion 644 passes over the pair of slats692 and the compressive force on the contact portion 644 is released.Due to the resilient nature of each lancet 624, the lancet tip 646springs to an uncompressed configuration. The lancet tip 646 moves in adirection orthogonal to the lancet frame 630 when the lancet 624 movesfrom the initial position to the incision forming position. As thelancet tip 646 moves, the lancet tip 646 pierces the skin of the userthat has been placed over the corresponding chamber 632. In oneembodiment, as the lancet tip 646 forms an incision, the body fluidsample from the incision travels along a capillary groove via capillaryaction towards the contact portion 644 and the capillary groove collectsthe body fluid sample from the incision while the lancet tip 646 is inthe skin of the user. After a driver or other mechanism reaches itsfinal extension position, the driver stops and reverses its path ofmovement. As the driver reverses its path of movement, the force appliedto the leg portion 642 is reduced and the lancet tip 646 withdraws fromthe incision. Since the lancet 624 has returned to an uncompressedconfiguration, the pair of tabs 645 slide behind the pair of slats 692to restrain the lancet 624 in a final position and allow the lancet tip646 to engage the test section 628. In its final position, the lancet624 rests against the test section 628 and the bodily fluid sample istransferred from the capillary groove or the lancet tip 646 to thecorresponding test section 628.

FIGS. 48A and 48B are schematic representations of one technique ofrestraining a lancet prior to actuation such that the lancet does notcontact the test section. As illustrated in FIG. 48A, the lancet restsagainst a notch in a frame such that the position of the frame resultsin a compressive force in the lancet. After the lancet is actuated, thelancet is released from the notch and returns to an uncompressed state.The lancet then forms an incision and collects a body fluid sample inthe lancet tip. As shown in FIG. 48B, the lancet tip in an uncompressedstate touches a test section to transfer the body fluid sample from thelancet to the test section. The position of the test section allows theuncompressed lancet to engage the test section and transfer the bodyfluid sample to it. Beneficially, the lancet does not contact the testsection unless the lancet is transferring a body fluid sample to thetest section therefore the test chemistry remains intact. Resiliency ofthe lancet allows it to return to an uncompressed state after it isreleased from the notch therefore no additional mechanisms are requiredto cause the lancet to return to an uncompressed state and transfer abody fluid sample to the test section.

FIGS. 49A and 49B are schematic representations of another technique ofrestraining a lancet prior to actuation such that the lancet does notcontact the test section. Beneficially, the test chemistry on the testsection remains intact and untouched. As shown in FIG. 49A, the lancetrests against a ledge such that the position of the ledge results in acompressive force in the lancet. After the lancet is actuated, thelancet is released from the ledge and returns to an uncompressed state.The lancet then forms an incision and collects a body fluid sample inthe lancet tip. As shown in FIG. 49B, the lancet tip in an uncompressedstate touches a test section to transfer the body fluid sample from thelancet to the test section. Beneficially no other mechanisms arerequired to cause the lancet to return to an uncompressed state andtransfer a body fluid sample to the test section. The position of thetest section allows the uncompressed lancet to engage the test sectionand transfer the body fluid sample to it.

FIGS. 50A and 50B are schematic representations of yet another techniqueof restraining a lancet prior to actuation such that the lancet does notcontact the test section therefore the test chemistry on the testsection remains intact and untouched. In a first position shown in FIG.50A, a first band restrains a lancet such that the position of the bandresults in a compressive force in the lancet and the lancet is flexed orbent. Next, the lancet is actuated and the lancet pierces through thefirst band to form an incision in skin and collect a body fluid sample.During actuation the lancet returns to its uncompressed shape. As shownin FIG. 50B, after collecting the body fluid sample the lancet tipcontacts a second band that includes a test section as the lancetreturns to the first position. The body fluid sample in the lancet tipis transferred from the lancet tip to the test section on the secondband.

FIGS. 51A and 51B are schematic representations of yet another techniqueof restraining a lancet prior to actuation such that the lancet does notcontact the test section therefore the test chemistry on the testsection remains intact and untouched. As shown in FIG. 51A, the lancettip rests in a cover made of a soft material such that the position ofthe cover results in a compressive force in the lancet. After the lancetis actuated, the lancet is driven through the soft cover and returns toan uncompressed state. After the lancet is driven through the cover, thecover then slides down a portion of the lancet as the lancet tip formsan incision and collects a body fluid sample. As shown in FIG. 51B, thelancet has returned to its original position and the lancet tip touchesa test section to transfer the body fluid sample from the lancet to thetest section. Beneficially no other mechanisms are required to cause theresilient lancet to return to an uncompressed state and transfer a bodyfluid sample to the test section. The position of the test sectionallows the uncompressed lancet to engage the test section and transferthe body fluid sample to it.

FIGS. 52A and 52B are schematic representations of one technique ofrestraining a lancet prior to actuation such that the lancet does notcontact the test section therefore the test chemistry on the testsection remains intact and untouched. As shown in FIG. 52A, the lancetincludes a tab that rides along a track such that the position of thetrack causes the lancet to bend or compress. After the lancet isactuated, the tab is driven along the track until the tab clears thetrack thereby releasing the compressive force on the lancet and thelancet returns to an uncompressed state. After the tab has cleared thetrack, the lancet tip forms an incision and collects a body fluidsample. As shown in FIG. 52B, the lancet tip touches a test section totransfer the body fluid sample from the lancet to the test section asthe lancet returns to its original position. Beneficially no othermechanisms are required to cause the resilient lancet to return to anuncompressed state and transfer a body fluid sample to the test section.The position of the test section allows the uncompressed lancet toengage the test section and transfer the body fluid sample to it.

FIGS. 53A and 53B are schematic representations of another technique ofrestraining a lancet prior to actuation such that the lancet does notcontact the test section therefore the test chemistry on the testsection remains intact and untouched. As shown in FIG. 53A, the lancetis in a bent configuration resting against a bottom layer of a lancetframe. In one form, the bottom layer is a sterility sheet. The bottomlayer of the lancet frame is configured such that the driver breaksthrough it. After forming an incision and collecting a body fluidsample, the lancet falls through the bottom layer of the lancet frame,and the lancet then touches a test section to transfer the body fluidsample from the lancet to the test section.

A portable meter system 1000 according to one embodiment is illustratedin FIGS. 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69,and 70. Although the portable meter system 1000 will be described withreference to portable blood glucose testing, it should be appreciatedthat the meter system 1000 can be adapted to test a wide variety ofbiological fluids and fluid properties. Looking at FIGS. 54 and 55, themeter system 1000 includes a housing 1002 that houses the lancet frame130, lancet wheel 122, and test ring 126. Schematically only lancetframe 130 is shown in the meter system 100 for clarity although themeter system 1000 will be described with reference to the lancet wheel122 and test ring 126. Although the portable meter system 1000 will bedescribed with reference to lancet frame 130, lancet wheel 122, and testring 126, it should be appreciated that the meter system 1000 can beadapted to the above listed cartridges and/or lancet frames, lancetwheels, and test rings.

The housing 1002 includes a front cover 1004, a door 1006, and a base1008 as illustrated in FIGS. 54 and 55. The front cover 1004 has adisplay 1012 for displaying test results as well as other information.It should be appreciated that the meter system 1000 can include otheroutput devices, like a speaker, for example. Display 1012 is positionedsuch that the user can readily view the display 1012 when the metersystem 1000 is gripped in the hand of the user. The door 1006 includes apressure cup 1014 sized to receive a fingertip of a user. The pressurecup 1014 is made from an elastic-type supported plastic material toallow for movement of the pressure cup 1014 to transfer force fromfinger pressure of the user to release arm 1020 in the meter system 1000to fire the lancet 124, as described in more detail below. The pressurecup 1014 is positioned over the lancet frame 130, lancet wheel 122, andthe test ring 126 to advance the lancet frame 130, lancet wheel 122, andthe test ring 126 for each lancing event. The pressure cup 1014 definesan opening 1015 in which the lancet 124 exits to form an incision inskin. The back surface of the pressure cup 1014 has a pair of triggercontact tabs 1016 positioned to engage a pair of tabs 1021 of releasearm 1020 to actuate the lancet 124, as described in more detail below.In one embodiment, the door 1006 is hingedly attached to the base 1008to allow access to the interior of the meter system 1000. As such, aused lancet frame 130, lancet wheel 122, and test ring 126 can bereplaced with a clean or new lancet frame, lancet wheel, and test ring.In other embodiments, the door 1006 can be attached to base 1008 byanother mechanism.

The portable meter system 1000 includes a release arm 1020. Release arm1020 has a pair of tabs 1021 configured to contact the pair of triggercontact tabs 1016. Release arm 1020 includes a trigger 1062 positionedto engage a latch and thereby release spring motor 1050. The portablemeter system 1000 also includes a first gear 1022, a second gear 1024,and a third gear 1026 that interact with each other to rotate the lancetframe 130, lancet wheel 122, and the test ring 126 to advance the lancetframe 130, lancet wheel 122, and the test ring 126 for each lancingevent. Gear 1026 is mounted to a platform 1028 in which the lancet frame130, lancet wheel 122, and the test ring 126 have also been attached.First gear 1022 is driven by fourth gear 1024, as described in moredetail below. Due to the interaction of gears 1022, 1024, and 1026, therotational movement of gear 1022 causes gears 1024 and 1026 to rotate.

The portable meter system 1000 has a lower printed circuit board 1030and an upper printed circuit board 1032 that are powered by a battery1034 as illustrated in FIGS. 64 and 65. The upper printed circuit board1032 is connected to the display 1012. The upper printed circuit board1032 includes an edge connector 1036. The lower printed circuit board1030 includes an edge connector socket or slot 1038. Edge connectorsocket 1038 is typically a female electrical connector for use with amale electrical connector such as edge connector 1036. When assembled,edge connector 1036 mates with edge connector socket 1038 to connectupper printed circuit board 1032 to lower printed circuit board 1030.

The portable meter system 1000 includes a motor 1040 that drives afourth gear 1042. A priming gear 1044 connects with the fourth gear 1042and a fifth gear 1046. The placement of the fourth gear 1042, priminggear 1044, and fifth gear 1046 enables the motor 1040 to have at leasttwo functions depending on the rotational direction of the gears 1042,1044, and 1046. If the fourth gear 1042 has a clockwise rotation bymotor 1040, then the lancet frame 130, lancet wheel 122, and test ring126 will be rotated for the next lancing, sampling, and testing event,as described in more detail below. If the fourth gear 1042 has acounterclockwise rotation by motor 1040, then the spring motor 1050 isprimed to drive the crank shaft 1070 and after triggering, cause alancing, sampling, and testing event, as described in more detail below.

As illustrated in FIGS. 60, 61, and 62, the portable meter system 1000includes a force spring 1060. The portable meter system 1000 alsoincludes a crank shaft 1070 that is connected to a crank arm 1072. Thecrank shaft 1070 has a dampener stop tab 1200, as illustrated in FIG.66. The crank arm 1072 is pivotally connected to a tip up link 1074. Thetip up link 1074 is connected to driver 136 that engages lancet 124. Theportable meter system 1000 includes a one-way clutch 1080 that extendsthrough fifth gear 1046 and a worm drive 1090. The portable meter system1000 has a first bearing cap 1092 and a second bearing cap 1094. Secondbearing cap 1094 has a hard stop 1096.

As illustrated in FIG. 63, the portable meter system 1000 includes aframe 1100. Frame 1100 supports motor 1040, crank shaft 1070, tip uplink 1074, one-way clutch 1080, and worm drive 1090. In particular, tipup link 1074 is pivotally mounted to frame 1100. Frame 1100 ispositioned next to the lower printed circuit board 1030.

FIGS. 67, 68, and 69 illustrate actuation of the lancet 124 by theportable meter system 1000. Crank shaft 1070, crank arm 1072, tip uplink 1074, driver 136, and lancet 124 are in an initial position asshown in FIG. 67. In FIG. 67, crank arm 1072 is in a 0 degree positionor a pre-incision forming position. A user places a finger against theopening 1015 and presses the pressure cup 1014 towards the base 1008.The pressure cup 1014 is configured to allow movement of the pressurecup 1014 to transfer force from the finger pressure to actuate thelancet 124 as follows. Pressure cup 1014 presses against the release arm1020 to transfer the force from the pair of trigger contact tabs 1016 tothe pair of tabs 1021 to move release arm 1020 towards the base 1008. Asrelease arm 1020 moves, trigger 1062 engages a latch and releases springmotor 1050 to drive the crank shaft 1070 and crank arm 1072.

As shown in FIG. 68, the crank shaft 1070 rotates crank arm 1072 in acounterclockwise direction approximately 90 degrees from the initialposition of the crank arm 1072. Crank arm 1072 correspondingly rotatesor pivots tip up link 1074 in a clockwise direction. Crank arm 1072 isnow at a 90 degree position or an incision forming position. As tip uplink 1074 rotates, driver 136 also rotates in a clockwise direction torotate the lancet tip 146 through the opening 1015 to form an incisionin skin and collect a body fluid sample. The lancet tip 146 is liftedinto a finger of a user in a few milliseconds. In one embodiment, thelancet tip 146 could be lifted into a finger in about three to fivemilliseconds. The movement of the crank shaft 1070 results in a“fast-in” position wherein the lancet 124 forms an incision in tissuequickly as compared to the withdrawal of the lancet 124 as describednext.

As shown in FIG. 69, the crank shaft 1070 continues to rotate crank arm1072 in a counterclockwise direction approximately 180 degrees from theincision forming position of the crank arm 1072. Dampener stop tab 1200engages the frame 1100 to slowly return the lancet 124 to its finalposition wherein the lancet tip 146 contacts a test section 128. Thisresults in a “slow-out” position wherein the lancet 124 returns to itsfinal position slowly as compared to the lancet forming an incision. Inone embodiment, the time required for the lancet tip 146 to form anincision is ten to one hundred times faster than the time required forthe lancet tip 146 to return to its final position. Crank arm 1072 isnow at a 270 degree position from the initial position of crank arm1072. At this position, the body fluid sample is transferred from thelancet tip 146 to a corresponding one of the plurality of test sections128. Tip up link 1074 is rotated in a counterclockwise direction tolower the driver 136 below the lancet frame 130 to clear the lancetframe 130 for rotation to an unused lancet 124 and a subsequent testingevent.

The crank shaft 1070 continues to rotate crank arm 1072 in acounterclockwise direction approximately 90 degrees from the body fluidtransferring position to the initial position for a subsequent lancing,sampling, and testing event.

A portable meter system 2000 according to one embodiment is illustratedin FIGS. 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, and 85.Common features from portable meter system 2000 and portable metersystem 1000 illustrated in FIGS. 54, 55, 56, 57, 58, 59, 60, 61, 62, 63,64, 65, 66, 67, 68, 69, and 70 will not be discussed for the sake ofbrevity. Looking at FIGS. 71 and 73, the meter system 2000 includes ahousing 2002 that houses the lancet frame 130, lancet wheel 122, andtest ring 126. Schematically only lancet frame 130 is shown in the metersystem 2000 for clarity although the meter system 2000 will be describedwith reference to the lancet wheel 122 and test ring 126. Although theportable meter system 2000 will be described with reference to lancetframe 130, lancet wheel 122, and test ring 126, the meter system 2000can be adapted to the above listed cartridges and/or lancet frames,lancet wheels, and test rings. Meter system 2000 includes an electronictriggering system and a penetration depth control adjustment systemwhereas meter system 100 does not include these features.

The housing 2002 includes a front cover 2004, a door 2006, and a base2008 as illustrated in FIG. 71. The front cover 2004 has a display 2012for displaying test results as well as other information. It should beappreciated that the meter system 2000 can include other output devices,like a speaker, for example. The door 2006 includes an opening 2015positioned over the lancet frame 130, lancet wheel 122, and test ring126. Upon actuation, lancet tip 146 exits opening 2015 to form anincision in skin. Meter system 2000 does not include a pressure cup inwhich to trigger a lancing, sampling, and testing event. Instead metersystem 2000 includes an electric force sensor (not shown) that senses ordetects the presence of a finger or other body part positioned over theopening 2015. After the finger force is detected on the opening 2015, amotor 2040 starts again and fires the lancet 124 to complete a lancing,sampling, and testing event, as described in more detail below.

Portable meter system 2000 includes a wheel 2001 for adjusting thepenetration depth of each of the plurality of lancets 124 for a lancingevent. Wheel 2001 is rotated to adjust the penetration depth of theactive one of lancets 124 to either a shallow depth setting or a deepdepth setting as described in more detail below. Initially, wheel 2001is mounted on a first end of a shaft 2200 such that one of the lancets124 is in a shallow depth setting as shown in FIG. 73. Mounted along amidpoint of shaft 2200 is a first lever 2202 that defines a first slot2204 as illustrated in FIG. 72. Mounted on an opposite end of shaft 2200is a second lever 2212 that is similar to first lever 2202. Second lever2212 defines a second slot 2214. A first end of a first pin 2206 isconfigured to fit in first slot 2204 and a second end of pin 2206 isconfigured to fit in the second slot 2214. The first pin 2206 ridesalong or slides in the first slot 2204 and the second slot 2214 as thefirst lever 2202 and the second lever 2212 are rotated corresponding torotation of wheel 2001 from a shallow depth setting to a deep depthsetting. The middle portion of first pin 2206 is configured to fitthrough a first opening 2232 defined in an intermediate arm 2230. Thefirst lever 2202 and the second lever 2212 work together or as a pair tocontrol the position of first pin 2206 which sets the depth setting toeither “shallow” or “deep” penetration.

As shown in FIG. 74, intermediate arm 2230 includes an upper half 2236that defines the first opening 2232. Intermediate arm 2230 also includesa lower half 2238 that includes a second pin 2082 that fits in andslides in a slot 2080 of tip up link 2074 as described below.

A tip up link 2074 is mounted on the shaft 2200. Tip up link 2074 isattached to the driver 136 that engages each of the lancets 124. Tip uplink 2074 defines a slot 2080 that is configured to receive the secondpin 2082 of the intermediate arm 2230.

Meter system 2000 also has a different actuation system than portablemeter system 1000. Meter system 2000 includes a crank shaft 2070 that issimilar to crank shaft 2070. Crank shaft 2070 includes a disk 2250 witha stopper 2252 that is configured to contact a crank arm 2072 in thefinal position of a used lancet as illustrated in FIGS. 75 and 78. Thecrank arm 2072 is similar to the crank arm 1072 however a first end ofcrank arm 2072 is rotatably mounted on the disk 2250. A second end ofthe crank arm 2072 is pivotably attached to the intermediate arm 2230.The crank shaft 2070 has a dampener stop tab 2201, as illustrated inFIG. 80. The second pin 2082 of intermediate arm 2230 slides in slot2080 of the tip up link 2074 to cause the tip up link 2074 andcorresponding driver 136 to rotate. The interaction of crank shaft 2070,crank arm 2072, intermediate arm 2230, and tip up link 2074 will bedescribed in more detail below.

Meter system 2000 has a priming gear 2044 that connects with a fourthgear 2042 and a fifth gear 2046 as shown in FIG. 73. Fourth gear 2042,priming gear 2044, and fifth gear 2046 are similar to fourth gear 1042,priming gear 1044, and fifth gear 1046 of meter system 1000.

Meter system 2000 includes an electronic triggering system as shown inFIGS. 82, 83, 84, and 85. A trigger cam 2280 having a catch 2282 ismounted to priming gear 2044. A catch-release pivot shaft 2047 ridesinside the catch 2282. The catch-release pivot shaft 2047 has a guide orfollower pin 2284. The follower pin 2284 travels along a cam groove 2286in gear 2044.

The portable meter system 2000 includes a motor 2040 that drives thefourth gear 2042. Similar to motor 1040, motor 2040 has at least twofunctions depending on the rotational direction of the gears 2042, 2044,and 2046. When motor 2040 is turned “on”, motor 2040 winds ¾ of arevolution and then motor 2040 stops. When the finger force is detectedon the opening 2015, the motor 2040 starts again and fires the lancet124.

Meter system 2000 can also be adjusted for either a shallow penetrationdepth setting or a deep penetration depth setting of a lancet 124 asdescribed next. As shown in FIG. 73, the pin 2206 positioned in thefirst slot 2204, the first opening 2232, and the second slot 2214 (notillustrated) is in an initial position of a shallow penetration depthsetting. If a deep penetration depth of an active one of the lancets 124is desired as shown in FIG. 76, then wheel 2001 is rotated which causesthe attached shaft 2200 to rotate and the first lever 2202 and secondlever 2212 (not illustrated) to pivot which in turn causes the pin 2206in the first slot 2204, the first opening 2232, and the second slot 2214(not illustrated) to move down or towards the crank arm 2072. After thewheel 2001 is rotated to a deep penetration depth setting, the pin 2206is positioned to cause the tip up link 2074 and driver 136 to rotate agreater distance and thereby force the active one of the lancets 124 tomove a greater distance and form a deeper incision.

FIGS. 73, 74, and 75 illustrate actuation of the active one of lancets124 by the portable meter system 2000 with the meter system 2000 in ashallow penetration depth setting with first pin 2206 positioned at thetop of first opening 2232 of intermediate arm 2230. Crank shaft 2070,crank arm 2072, intermediate arm 2230, tip up link 2074, driver 136, andlancet 124 are in an initial position as shown in FIG. 73. In FIG. 73,crank arm 2072 is in a 0 degree position or a pre-incision formingposition. A user turns “on” motor 2040 to cause motor 2040 to windthree-fourths of a revolution and then stop. A user places a fingeragainst the opening 2015. The electric sensor senses the finger forceand the motor 2040 starts again. The spring motor 2050 is wound onerevolution from the interaction of the motor 2040, fourth gear 2042, andpriming gear 2044. Catch-release pivot shaft 2047 is then activated torelease spring motor 2050 to drive the crank shaft 2070 and crank arm2072.

As shown in FIG. 74, the crank shaft 2070 rotates crank arm 2072 in acounterclockwise direction approximately 90 degrees from the initialposition of the crank arm 2072. Crank arm 2072 correspondingly rotatesor pivots intermediate arm 2230 and tip up link 2074 in a clockwisedirection. The second pin 2082 of intermediate arm 2230 is in the topposition of slot 2080 of the tip up link 2074 to cause the tip up link2074 and corresponding driver 136 to rotate the driver 136 towards theopening 2015. Crank arm 2072 is now at a 90 degree position or anincision forming position. As tip up link 2074 rotates, driver 136 alsorotates in a clockwise direction to rotate the lancet tip 146 throughthe opening 2015 to form an incision in skin and collect a body fluidsample. The lancet tip 146 is lifted into a finger of a user in a fewmilliseconds. In one embodiment, the lancet tip 146 could be lifted intoa finger in about three to five milliseconds. The movement of the crankshaft 2070 results in a “fast-in” position similar to the crank shaft1070 of meter system 1000.

As shown in FIG. 75, the crank shaft 2070 continues to rotate crank arm2072 in a counterclockwise direction approximately 180 degrees from theincision forming position of the crank arm 2072. Stopper 2252 contactsthe crank arm 2072 and dampener stop tab 2200 engages a frame 2100 (notillustrated) to slowly return the lancet 124 to its final positionwherein the lancet 124 contacts a test section 124. This results in a“slow-out” position similar to meter system 1000. In one embodiment, thetime required for the lancet tip 146 to form an incision is twice asfast as the time required for the lancet tip 146 to return to its finalposition. Crank arm 2072 is now at a 270 degree position from theinitial position of crank arm 2072. At this final position, the bodyfluid sample is transferred from the lancet tip 146 to a correspondingone of the plurality of test sections 128. As shown in FIG. 75, thesecond pin 2082 of intermediate arm 2230 is in the bottom of slot 2080of the tip up link 2074 to cause the tip up link 2074 and correspondingdriver 136 to rotate the driver 136 below the lancet frame 130 such thatthe driver 136 has cleared the lancet frame 130 for rotation of thelancet frame 130 to an unused lancet 124 and a subsequent testing event.

The crank shaft 2070 reverses its direction to rotate crank arm 2072 ina clockwise direction approximately 270 degrees from the body fluidtransferring position to the initial position for a subsequent lancing,sampling, and testing event.

FIGS. 76, 77, and 78 illustrate actuation of the lancet 124 by theportable meter system 2000 with the meter system 2000 in a deeppenetration depth setting. The wheel 2001 is rotated to lower the firstpin 2206 to the bottom of first opening 2232 of intermediate arm 2230and force the tip up link 2074 and driver 136 to rotate further than theshallow depth setting to cause a deeper penetration depth of the activeone of the lancets 124. Crank shaft 2070, crank arm 2072, intermediatearm 2230, tip up link 2074, driver 136, and lancet 124 operate asdescribed previously with respect to FIGS. 73, 74, and 75.

Another embodiment concerns keeping the sampling member off the testelement in a common space until use, where only the sampling member isactuated. Accordingly with regard to a device it is proposed that thetest member is fixed in a retaining chamber of the container, and thesampling member is configured in the same retaining chamber such that itis separated at a distance from the test member in an initial state andis in contact with the test member to transfer body fluid in a transferstate after the skin-piercing. In this manner it is possible to avoid acontamination of the sampling member especially with loose chemistryparticles of the test element before the skin contact. Further, thefixed connection of the test member in the container facilitatesmanufacture of the disposable and allows a simplified sample transfer,while ensuring a safe disposal of the used and potentially bio-hazardousmaterial. Accordingly, the sampling member is actuated to carry out apiercing movement outwards and backwards into the container, and thetest member is arranged stationary inside the container.

One embodiment stipulates that the sampling member is separated from thetest member by means of a spacer which can be put out of function duringthe skin-piercing. In order to provide a free space between the samplingmember and the test member in the initial state, the spacer extends overa distance in direction of a piercing movement of the sampling member.

Advantageously, the spacer is removable by an actuator configured toactuate piercing movement of the sampling member. In this respect it isbeneficial if the spacer is formed, preferably with a predeterminedbreaking point, at a wall of the container defining the retainingchamber, and is cut off the wall to achieve the transfer phase.Alternatively, it is possible that the spacer is connected to thesampling member, and a stopper of the container is removable such thespacer is inoperable in the transfer state.

Another improvement is achieved in that the sampling member is urgedagainst the test member by means of a resilient element, thus ensuringan automatic sample transfer. In this configuration, the sampling memberis deflected against a restoring force of the resilient element duringthe skin-piercing. This can be realized by a sampling member that has aflexible bending link forming the resilient element. In addition it isadvantageous when the sampling member is formed as a hooked needle, anda spring-arm of the hooked needle is pre-tensioned against the testmember.

For the application it is also advantageous the sampling member has atip to pierce the skin and a capillary structure to uptake body fluid,wherein the capillary structure is in fluidic connection with the testelement during the transfer phase. A preferred embodiment provides thatthe sampling member comprises a pointed piercing arm, and a laterallyopen channel is extending along the piercing arm preferably having abent section that can be contacted with the test member.

In order to precisely define the actuation, the sampling member maycomprise an engagement slot to receive an actuator rod for driving apiercing movement.

For the application it is also advantageous when the test member isformed as a reagent pad having a reactive layer which is sensitive to ananalyte in the body fluid, and the flat-material pad is attached to awall of the container defining the retaining chamber. In thisconfiguration it is possible that the test member is configured to bemounted in the container as a unit separate from the sampling member.

Another improvement is achieved in that the container is sealed againstthe environment by a sealing foil, and at least a piercing part of thesampling member is penetrated through the sealing foil to allow theskin-piercing. The container can include a wall structure which definesthe retaining chamber and comprises a desiccant material to keep thetest chemistry dry.

A further advantage in usability is achieved when the container isformed as a magazine to contain a plurality of sampling members and testmembers preferably arranged in pairs in respective retaining chambers.To achieve a compact design, it is advantageous when the containercomprises a disk-like configuration and contains a plurality of samplingmembers formed as a lancet wheel, and when the sampling members areactuated through a side face of the disk.

It is advantageous for a mass production when the lancet wheel is formedin one piece preferably by etching or cutting a metallic sheet material.It is further beneficial when the container includes a hub to engage arotary drive for successive rotary positioning of the sampling memberswith respect to a sampling port of the apparatus constructed to receivethe body part.

One embodiment also concerns a process for analyzing body fluidespecially for blood sugar tests in which a container is inserted into ameasuring apparatus, a sampling member provided in the container isactuated to pierce skin of a body part and sample body fluid, and bodyfluid obtained by the skin-piercing is transferred to a test member,wherein the test member is stationarily maintained in a retainingchamber of the container, and the sampling member is separately held ata distance from the test member in an initial state and is brought incontact with the test member to transfer body fluid in a transfer stateafter the skin-piercing.

The apparatus 3010 shown in FIG. 86 allows self-withdrawal of a bloodsample by a user for analytical purposes and in particular for bloodsugar monitoring. It comprises a housing 3012 with a lid 3014 to allowthe change of a disposable test container or cartridge 3016. In theclosed state, a body part and in particular a fingertip can be pressedagainst a port 3018 of the lid 3014 in order to take a blood sample byskin-piercing. The apparatus 3010 further comprises drive and processingunits for an automatic measurement operation (not shown). Themeasurement result can be indicated on a display 3020.

As shown in FIG. 87, the cartridge 3016 comprises a disk-likeconfiguration where the side faces are sealed against the environment byfoils 3022. The inner space between the foils is divided in sectors by awall structure 3024. Thereby, a magazine with a plurality of retainingchambers 3026 is defined to accommodate in each chamber a samplingmember 3028 and a test member 3030 in pair-wise configuration. The wallstructure 3024 can be formed as a single frame by injection molding witha desiccant material co-molded to keep the chambers 3026 free frommoisture. It is further conceivable to photo-etch or cut and thenpre-form the plurality of sampling members 3028 as a one piece lancetwheel 3032 that can be inserted into the frame 3026. In order tosuccessively position the sampling members 3028 with respect to the port3018, the frame 3026 includes a hub 3034 for engaging a rotary drive ofthe apparatus 3010.

FIG. 88 shows an initial configuration of a retaining chamber 3026 withthe sampling member 3028 being held at a distance with respect to thetest member 3030 by means of a spacer 3036. Due to the free space 3038kept by the spacer 3036, the sampling member 3028 is held off thechemistry film of the test member 3030 until the test is performed.

The sampling member 3028 is formed as a hooked needle, which isaccessible for actuation and allows piercing by break-through of thefoils 3022. For collecting a small amount of blood from a body part, thesampling member 3028 comprises a pointed tip 3040 and a capillarychannel 3042. The channel 3042 is laterally open along its length andextends into a curved section 3044 facing the test member 3030. Thesampling member 3028 is linked to the periphery of the frame 3026 via aflexible spring-arm 3046. The spring-arm 3046 is under pretension, suchthat the section 3044 including the proximal part of the channel 3042 isurged against the removable spacer 3036 and the test member 3030,respectively.

In order to allow a blood transfer from the channel 3042 onto the testmember 3030, the spacer 3036 can be removed during the skin-piercingprocedure. This is facilitated by means of a breaking point 3048 at thebasis of the spacer 3036. Alternatively, it is possible that the spacer3036 is connected to the sampling member and abuts a removablecounterpart, e.g. the sealing foil 3022.

The test member 3030 is formed as a reagent pad having a reactive layer3050. The reagent pad can be mounted as a unitary ring which is fixed tothe bottom of the frame 3026. The reactive layer 3050 comprises a driedenzyme chemistry which is sensitive to blood glucose, such that a colourchange occurs which can be optically detected through the transparentframe 3026. The detection of blood glucose in particular by means ofcontact-free optical methods is known in the prior art and is thereforenot elucidated in more detail here.

FIGS. 89, 90, and 91 illustrate the sampling and transfer procedure,where the sampling member 3028 is actuated to carry out a piercingmovement outwards and backwards (arrows 3052, 3054) into the respectiveretaining chamber 3026 of the cartridge 3016, while the test member iskept stationary.

In the forward movement 3052, the sampling member 3028 is deflectedagainst the restoring force of the spring-arm 3046 by means of anactuator rod 3056. The rod 3056 is driven in direction of arrow 3058 bya drive unit of the apparatus, thereby penetrating the bottom foil 3022and sliding along the spring-arm 3046. It is also conceivable that therod 3056 is provided with an engaging piece for a form-lockingengagement with the sampling member (not shown). While the actuator rod3056 is accessing the spring-arm 3046, the needle tip 3040 is breakingthrough the upper foil 3022 and pierces the skin of the fingertipapplied on the port 3018. During the skin-piercing, blood and/orinterstitial liquid is received in the channel 3042 preferably bycapillary action.

During the following resilient retraction 3054 of the sampling member,the actuator rod 3056 engages the spacer 3036 with a hook piece 3060(FIG. 90). Subsequently, the rod 3056 is pulled back in direction ofarrow 3062, whereby the spacer 3036 is torn off the frame 3026 (FIG.91). This allows contact of the curved section 3044 of the samplingmember 3028 with the test element 3030, thereby initiating a transferphase in which the sampled liquid is automatically transferred to thetest element for an immediate analysis.

While the invention has been illustrated and described in detail in thedrawings and foregoing description, the same is to be considered asillustrative and not restrictive in character, it being understood thatonly the preferred embodiment has been shown and described and that allchanges, equivalents, and modifications that come within the spirit ofthe inventions defined by following claims are desired to be protected.All publications, patents, and patent applications cited in thisspecification are herein incorporated by reference as if each individualpublication, patent, or patent application were specifically andindividually indicated to be incorporated by reference and set forth inits entirety herein.

What is claimed is:
 1. A disposable device for analyzing body fluid,comprising: a container which can be inserted into a measuringapparatus, the container having a disk-like configuration and containinga plurality of sampling members formed as a lancet wheel, each of thesampling members having a proximal body portion and a distal skinpiercing tip extending at an angle from the proximal body portion toform a contact portion between the proximal body portion and the distalskin piercing tip, the proximal body portion attached to a rim of thelancet wheel, the distal skin piercing tip configured to pierce skin ofa body part, and the contact portion disposed at a bend between theproximal body portion and the distal skin piercing tip configured fortransfer of a body fluid sample; a plurality of test memberscorresponding to the plurality of sampling members for receiving bodyfluid obtained by the skin-piercing, wherein the plurality of testmembers are fixed in a plurality of retaining chambers of the container;and wherein each of the sampling members is configured to move from aninitial state wherein the sampling member does not contact the testmember to a skin-piercing state wherein the sampling member rotates awayfrom the test member to form an incision in skin, and further whereineach of the sampling members is configured to move from theskin-piercing state to a transfer state wherein the sampling memberrotates towards the test member so that the contact portion is influidic connection with the test member to transfer body fluid after theskin-piercing.
 2. The device according to claim 1, wherein the samplingmember is actuated to carry out a piercing movement outwards andbackwards into the container, and the test member is arranged stationaryinside the container.
 3. The device according to claim 1, wherein thesampling member is separated from the test member by means of a spacerin the initial state and the sampling member is configured to move awayfrom the spacer and the test member during the skin-piercing.
 4. Thedevice according to claim 3, wherein the spacer extends over a distancein direction of a piercing movement of the sampling member in order toprovide a free space between the sampling member and the test member. 5.The device according to claim 3, wherein the spacer is removable by anactuator configured to actuate piercing movement of the sampling member.6. The device according to claim 3, wherein the spacer is formed with apredetermined breaking point, at a wall of the container defining theretaining chamber, and that the spacer is cut off the wall to achievethe transfer state.
 7. The device according to claim 3, wherein thespacer is connected to the container, and the spacer is removable in thetransfer state.
 8. The device according to claim 1, wherein the samplingmember is urged against the test member by means of a resilient element.9. The device according to claim 8, wherein the sampling member isdeflected against a restoring force of the resilient element during theskin-piercing.
 10. The device according to claim 9, wherein the samplingmember has a flexible bending link forming the resilient element. 11.The device according to claim 1, wherein the sampling member is formedas a hooked needle and a spring-arm of the hooked needle ispre-tensioned against the test member.
 12. The device according to claim1, in which the sampling member has a capillary structure to uptake bodyfluid, wherein the capillary structure is in fluidic connection with thetest member during the transfer state.
 13. The device according to claim1, wherein the sampling member comprises a piercing arm that includesthe skin piercing tip, and a laterally open channel is extending alongthe piercing arm to the contact portion that can be contacted with thetest member to transfer body fluid.
 14. The device according to claim 1,wherein the sampling member has an engagement slot to receive anactuator rod for driving a piercing movement.
 15. The device accordingto claim 1, wherein the test member is formed as a reagent pad having areactive layer which is sensitive to an analyte in the body fluid, andthe reagent pad is attached to a wall of the container defining theretaining chamber.
 16. The device according to claim 1, wherein the testmember is configured to be mounted in the container as a unit separatefrom the sampling member.
 17. The device according to claim 1, whereinthe container is sealed against the environment by a sealing foil, andat least a piercing part of the sampling member is penetrated throughthe sealing foil to allow the skin-piercing.
 18. The device according toclaim 1, wherein the container includes a wall structure which definesthe retaining chamber and comprises a desiccant material.
 19. The deviceaccording to claim 1, wherein the container is formed as a magazine tocontain a plurality of sampling members and test members arranged inpairs in respective retaining chambers.
 20. The device according toclaim 1, wherein the sampling members are actuated through a side faceof the disk.
 21. The device according to claim 20, wherein the lancetwheel is formed in one piece by etching or cutting a metallic sheetmaterial.
 22. The device according to claim 1, wherein the containerincludes a hub to engage a rotary drive for successive rotarypositioning of the sampling members with respect to a sampling port ofthe apparatus constructed to receive the body part.
 23. An apparatus,comprising: an integrated cartridge having drop-in assembly ofcomponents, including a test ring component having a plurality of testsections; a lancet wheel component having a lancet rim with a pluralityof lancets extending radially inward from the lancet rim, each of thelancets having a leg portion and a lancet tip extending substantiallytransverse to the leg portion to form a curved contact portiontherebetween wherein the curved contact portion is in fluidic connectionwith the lancet tip, wherein the curved contact portion is configured tocontact one of the plurality of test sections to deposit a body fluidsample on the test section; and a frame component having an egg crateshape with a plurality of chambers to facilitate drop-in assembly of thelancet wheel component onto the frame component.
 24. The apparatus ofclaim 23, further comprising: the test ring component having acontinuous strip of chemistry that spans a circumference of the testring component, the test ring component being sectionable into theplurality of the test sections; and wherein the plurality of chambersare configured to section the test ring component into the plurality ofthe test sections and each of the lancets is positioned next to one testsection.
 25. The apparatus of claim 24, wherein the leg portion isresilient to move between a first position wherein the lancet tip formsan incision and a second position wherein the curved contact portioncontacts the test section.
 26. The apparatus of claim 25, furthercomprising: wherein the frame component defines a plurality of windowssized to receive the contact portion of the lancet; and a plurality ofcover barriers positioned between the lancet rim and the test ringcomponent to cover the plurality of windows, each of the cover barriersdefining a slot sized to receive the contact portion of the lancet, theplurality of cover barriers movable between a first position wherein thecover barriers cover the windows and a second position wherein the slotsalign over the windows to expose the test section under the coverbarriers and allow the curved contact portion of the lancet to contactthe test section.
 27. The apparatus of claim 24, further comprising: afirst sterility sheet configured to cover the plurality of chambers andthe plurality of lancet tips; wherein the frame component includes aplurality of openings sized to receive a driver; and a second sterilitysheet configured to cover the plurality of openings and the plurality ofchambers, wherein the test ring component, the first sterility sheet,and the second sterility sheet maintain the sterility of unused lancetsand the humidity of unused test sections.
 28. The apparatus of claim 23,wherein the lancet tip is configured to form an incision in skin and thelancet tip includes a capillary groove configured to collect the bodyfluid sample via capillary action.
 29. The apparatus of claim 23,further comprising: a meter, the meter having the integrated cartridgestored in the meter; and a driver configured to engage the leg portionof the lancet to rotate the lancet to form an incision in skin with thelancet tip.
 30. The apparatus of claim 23, further comprising: aplurality of wedges made of a desiccant material, wherein one of thewedges is positioned in each chamber of the frame component.
 31. Theapparatus of claim 23, further comprising: the test ring componenthaving a continuous strip of chemistry that spans a circumference of thetest ring component, the test ring component being sectionable into theplurality of test sections, wherein the plurality of chambers areconfigured to section the test ring component into the plurality of testsections and each of the lancets is positioned next to one test section,and a test ring frame defining a plurality of windows configured toreceive the test ring component and to facilitate viewing of theplurality of test sections through the plurality of windows.
 32. Theapparatus of claim 31, further comprising: wherein the test ring framedefines a plurality of tester openings sized to receive a lancet tip ofthe lancet, a first sterility sheet configured to cover the plurality oftester openings and the plurality of lancet tips; and a second sterilitysheet configured to cover the plurality of chambers of the framecomponent, wherein the test ring component, the first sterility sheet,and the second sterility sheet maintain the sterility of unused lancetsand the humidity of unused test sections.
 33. The apparatus of claim 24,wherein the leg portion is resilient to move between a first positionwherein the lancet tip forms an incision and a second position whereinthe curved contact portion contacts the test section.
 34. The apparatusof claim 23, wherein the frame component includes a plurality of slats,and a pair of the plurality of slats are positioned in each of theplurality of chambers to contact and to restrain the lancet prior to alancing event and after the lancing event.
 35. A method, comprising:assembling an integrated disposable cartridge, wherein said assemblingincludes dropping a lancet wheel into a circular frame, the lancet wheelhaving a rim with a plurality of radially inwardly extending lancets,each of the lancets having a leg portion and a lancet tip extending atan angle from the leg portion to form a contact portion between the legportion and the lancet tip, wherein the contact portion is in fluidicconnection with the lancet tip and is configured to contact a testsection to deposit a body fluid sample on the test section, the framehaving a plurality of spokes defining a plurality of chambers;positioning each of the lancets in one of the chambers; attaching a testring having a continuous strip of chemistry onto the frame; andsectioning the test ring into a plurality of test sections by theplurality of spokes, each of the test sections positioned under one ofthe lancets such that each of the lancets is configured to rotate awayfrom the test section to form an incision.
 36. The method of claim 35,wherein said assembling further includes: positioning a plurality ofmovable cover barriers between the plurality of lancets and theplurality of test sections to eliminate contact between the lancet andthe test section until the lancet and the corresponding cover barrierare actuated, wherein each of the cover barriers defines a window toexpose a portion of the test section for contact by the lancet.
 37. Themethod of claim 35, further comprising: forming an incision in tissuewith one of the lancet tips wherein the leg portion is in a firstposition that is substantially parallel to the corresponding testsection; and transferring a body fluid sample from the contact portionto the test section wherein the leg portion is in a second positioncloser to the corresponding test section.
 38. The method of claim 35,further comprising: loading the integrated disposable cartridge into ameter configured to actuate the plurality of lancets.
 39. The method ofclaim 35, further comprising: dropping a desiccant wheel into thecircular frame, the desiccant wheel having a rim with a plurality ofwedges, and positioning each of the wedges in one of the chambers.
 40. Amethod, comprising: providing an integrated disposable cartridgeincluding a frame, a lancet wheel having a plurality of lancetsextending radially inward from a rim, and a test ring having a pluralityof test sections, each of the plurality of lancets has a lancet tip thatextends at an angle from a leg portion to define a contact portionbetween the lancet tip and the leg portion, the lancet tip having acapillary groove that extends to the contact portion, wherein thecontact portions are configured to contact the plurality of testsections; forming an incision in tissue with one of the lancets byrotating the lancet away from the plurality of test sections; collectinga body fluid sample with the capillary groove on the lancet; withdrawingthe lancet from the incision in tissue by rotating the lancet towardsthe plurality of test sections; and transferring the body fluid samplefrom the capillary groove on the lancet to one of the test sections bycontacting the test section with the contact portion of the lancet torelease the body fluid sample.
 41. The method of claim 40, furthercomprising: wherein the rotating the lancet away from the plurality oftest sections includes moving a driver towards the lancet in ahorizontal direction relative to the frame to contact the lancet; andwherein the rotating the lancet towards the plurality of test sectionsincludes moving the driver away from the lancet in a horizontaldirection relative to the frame.
 42. The method of claim 40, furthercomprising: indexing the frame to an unused lancet after transferringthe body fluid sample in the capillary groove to the test section. 43.The method of claim 40, further comprising: forming a second incision inskin with the lancet to obtain an adequate amount of body fluid sample.44. An apparatus, comprising: an integrated cartridge having drop-inassembly of components, including a lancet wheel component having alancet rim with a plurality of lancets extending radially inward fromthe lancet rim, each of the lancets having means for forming an incisionin skin and means for transferring a body fluid sample to a testelement, a frame component having an egg crate shape with a plurality ofchambers to facilitate drop-in assembly of the lancet wheel componentonto the frame component, a test ring component having a continuousstrip of chemistry that spans a circumference of the test ringcomponent, the test ring component being sectionable into a plurality oftest elements, and wherein the plurality of chambers are configured tosection the test ring component into the plurality of test elements andeach of the lancets is positioned next to one test element such that themeans for transferring the body fluid sample is in fluidic contact withthe one test element to deposit the body fluid sample.
 45. The apparatusof claim 44, wherein the means for transferring the body fluid sampleincludes the lancet having a contact portion to contact the test elementand deposit the body fluid sample on the test element.
 46. The apparatusof claim 44, wherein the means for transferring the body fluid sampleincludes the lancet having a lancet tip to contact the test element anddeposit the body fluid sample on the test element.
 47. The apparatus ofclaim 44, wherein the frame component includes a plurality of ledges andeach of the plurality of ledges defines a notch configured to receive alancet tip.
 48. The apparatus of claim 44, wherein the frame componentincludes a plurality of slats and a pair of the plurality of slats arepositioned in each of the plurality of chambers to contact and torestrain one of the plurality of lancets.
 49. An apparatus, comprising:an integrated cartridge having drop-in assembly of components, includinga lancet wheel component having a plurality of lancets, each of thelancets having a leg portion and a lancet tip extending substantiallytransverse to the leg portion to form a contact portion therebetween,and a frame component having a plurality of chambers to facilitatedrop-in assembly of the lancet wheel component onto the frame component;a test ring component having a continuous strip of chemistry that spansa circumference of the test ring component, the test ring beingsectionable into a plurality of test sections, wherein the plurality ofchambers are configured to section the test ring component into theplurality of test sections and each of the lancets is positioned next toone test section; and wherein the leg portion is resilient to movebetween a first position wherein the lancet tip forms an incision and asecond position wherein the contact portion is in fluidic connectionwith the test section to deposit a body fluid sample.